filter and filter preparation method

专利摘要:
TABULAR FILTER. The present invention relates to a filter (300) to be placed in a blood stream through a vessel. The filter includes a hub (310) disposed along a longitudinal geometric axis and a plurality of anchoring elements (330) extended from the hub. Each anchoring element includes a cranial extension (340) or a caudal extension (350) to a distal end thereof. At least one distal end of the anchoring element is spaced from the hub in each of the first, second, and third distances along the longitudinal geometric axis. The filter also includes a plurality of locating elements (320) extending from the hub, the locating elements alternately interposed between the anchoring elements.
公开号:BR112012001978B1
申请号:R112012001978-3
申请日:2010-07-29
公开日:2020-12-01
发明作者:Andrzej J. Chanduszko；Michael Adam Randall
申请人:C.R. Bard, Inc.；
IPC主号:

专利说明:

PRIORITIES
The present application claims the priority benefit of US Provisional Patent Application No. 61 / 229,580, filed on July 29, 2009, and is partly a continuation of US Patent Application No. 11 / 429,975, filed on May 9, 2006 , which claims the priority benefit of US Provisional Patent Application No. 60 / 680,601, filed on May 12, 2005. Each of the aforementioned applications is incorporated by reference in its entirety into this application. BACKGROUND
In recent years, a number of medical devices have been designed, which are adapted for compression in a small size in order to facilitate the introduction into a vascular passage and for further expansion in contact with the walls of the passage. These devices, among others, include blood clot filters that expand and hold in position depending on their involvement with the internal wall of a vein, as in the vena cava. These vena cava filters are designed to remain in place permanently. These filters include a structure for anchoring the filter in place within the vena cava, for example, divergent and elongated anchoring elements with hooked ends that penetrate the vessel wall and positively prevent migration in any direction in the longitudinal direction of the vessel . The hooks on filters of this type are rigid and do not bend, and within two to six weeks after the implantation of this type of filter, the endothelium layer grows over the divergent anchoring elements and positively holds the hooks in place. From this moment on, any attempt to remove the filter will result in a risk of injury or rupture of the vena cava.
A number of medical conditions and procedures subject the patient to a short-term risk of pulmonary embolism, which can be relieved by a filter implant. In such cases, patients are often averse to receiving a permanent implant, as the risk of pulmonary embolism may disappear only after a period of several weeks or months. However, most existing filters are not easily removable or safely removable after they have remained in place for more than a few weeks and, consequently, the longer term temporary filters that do not result in the likelihood of damage to the wall of the after removal are not available.
In an attempt to provide a removable filter, two filter baskets were produced along a central axis of a conical configuration, with each basket being formed by spaced supports that radiate outwardly from a central hub to the basket . The central cubes are kept apart by means of a compression unit, and the locating elements of the two baskets overlap so that the baskets are facing each other. Filters of this type require the use of two removal devices inserted at each end of the filter in order to separate the baskets and break the compression unit. The end sections of the locating elements are formed so as to rest in a relationship substantially parallel to the vessel wall and the tips are angled inward to prevent penetration of the vessel wall. When such a device is removed before the endothelium layer grows over the locating elements, damage to the vessel wall is minimal. However, after the growth of the endothelium layer, the combined inward and longitudinal movement of the filter sections, as far as they are apart, may tear that layer.
Each of the patents and patent applications published below refers to an IVC or blood filters, these documents being incorporated, by reference, in their entirety, to this application: USPN 5,059 205; USPN 6,007,558; USPN 6,273,901; USPN 6,287,332; USPN 6,589,266; USPN 7,338,512; USPN 7 544 202; USPN 7 625 390; US Publication No. 2007/0167974; US Publication No. 2007/0198050; US Publication No. 2008/0039891; WO 1999/025252; WO Publication 2002/0004060; u Publication WO 2004/098459; WO 2004/098460; WO Publication 2005/072645; WO 2005/102437; WO 2005/102439; WO 2006/036457; WO Publication 2006/124405; Publication WO 2007/100619 and Publication WO 2007/106378. BRIEF SUMMARY
The various modalities provide a removable blood filter that allows the filtering of a plunger in a blood vessel, using a plurality of locators and a plurality of anchors. In one aspect, a filter to be placed in a blood stream through a vessel includes a cube, at least one anchor, and at least one locator. The cube can be arranged along a longitudinal geometric axis. At least one anchor protrudes from the cube and includes a hook that penetrates a wall of the blood vessel when the filter is placed in the blood vessel. The hook can be spaced along the longitudinal axis of the cube and spaced at a first radial distance from the longitudinal axis. The at least one locator has a tip or portion of the locator that fits on the vessel wall. The tip may be spaced along the longitudinal axis of the cube and spaced a second radial distance from the longitudinal axis. The second radial distance may be less than the first radial distance. The at least one locator has at least four portions and each portion can be arranged on respective distinct axes.
In another aspect, the different modalities also provide a filter to be placed in a blood flow through a vessel. The filter includes a hub, at least one anchor and at least one locator. The cube can be arranged along a longitudinal geometric axis. The at least one anchor protrudes from the cube and includes a hook that penetrates a wall of the blood vessel when the filter is placed in the blood vessel. The hook can be spaced along the longitudinal axis of the cube and spaced at a first radial distance from the longitudinal axis. The at least one locator protrudes from the cube and has a tip or portion of the locator that fits on the vessel wall. The tip may be spaced along the longitudinal geometric axis of the cube and spaced at a second radial distance from the longitudinal geometric axis, the second radial distance being less than the first radial distance. The locator can be arranged close to the cube and has at least four portions, and each of the at least four portions can be arranged on respective distinct axes. The at least four portions can include a curved portion that is arranged over a radius of curvature that extends along the longitudinal geometric axis.
In yet another aspect of the various embodiments, a filter is provided to be placed in a blood stream through a vessel. The filter includes a hub, at least one anchor and at least one locator. The cube can be arranged along a longitudinal geometric axis. The at least one anchor protrudes from the cube and includes a hook that penetrates a wall of the blood vessel when the filter is placed in the blood vessel, spaced along the longitudinal geometric axis of the cube, and spaced at a first radial distance from the longitudinal geometric axis. The at least one locator protrudes from the cube and has a tip or portion of the locator that fits on the vessel wall. The tip may be spaced along the longitudinal geometric axis of the cube, and spaced at a second radial distance from the longitudinal geometric axis, the second radial distance being less than the first radial distance. The locator has a first distal portion of the cube and a second portion proximal to the cube. Each of the first and second portions can, in general, be linear and arranged on distinct oblique axes with respect to the longitudinal geometric axis, the length of the first portion being greater than the length of the second portion.
In yet another aspect of the various embodiments, a filter is provided to be placed in a blood stream through a vessel. The filter includes a hub, at least one anchor and at least one locator. The cube can be arranged along a longitudinal geometric axis. At least one anchor protrudes from the cube and includes a hook that penetrates a wall of the blood vessel, spaced along the longitudinal geometric axis of the cube, and spaced at a first radial distance from the first longitudinal geometric axis. The at least one locator protrudes from the cube and has a tip or portion of the locator that fits on the vessel wall. The tip may be spaced along the longitudinal geometric axis of the cube, and spaced at a second radial distance from the longitudinal geometric axis, the second radial distance being less than the first radial distance. The locator has a first and second portion oblique to the longitudinal geometric axis. The first portion may be distal to the cube, and a second portion may be proximal to the cube, the length of the first portion being greater than the length of the second portion. In another aspect of the various embodiments, a filter is provided to be placed in a blood vessel that includes a blood vessel wall. The filter includes a cube, and a first and a second set of elements. The cube can be arranged along a longitudinal geometric axis. Each of the first set of elements extends from the cube. Each of the first set of elements includes a hook spaced along the longitudinal geometric axis of the cube, each hook being spaced radially from the longitudinal geometric axis at a first distance. Each of the second set of elements extends from the cube and includes a tip that is spaced along the longitudinal geometric axis of the cube. Each tip can be spaced radially from the longitudinal axis at a second distance less than the first distance.
In yet another additional aspect of the various embodiments, a filter to be placed in a blood vessel is provided. The filter includes a cube, a plurality of anchors and a plurality of locators. The cube can be arranged along a longitudinal geometric axis. The plurality of anchors branches off from the cube. Each anchor includes a hook that: (i) penetrates a wall of the blood vessel, (ii) can be spaced along the longitudinal geometric axis of the cube, and (iii) can be spaced radially from the longitudinal geometric axis at a first distance. The plurality of locators branches off from the cube. Each locator includes a base portion close to the cube, a first portion extending from the base portion and along a first geometry axis, a second portion extending from the first portion and over a second geometric axis, which can be distinguished from the first geometric axis, and a point portion extending from the second portion and along a geometric point axis, which can be distinguished from the first and second axes. The tip portion (i) fits into the blood vessel wall, (ii) can be spaced along the longitudinal geometric axis of the 10 cube, and (iii) can be spaced radially from the longitudinal geometric axis at a second distance, which may be less than the first radial distance.
In yet another additional aspect of the various modalities, a filter to be placed in a blood vessel is provided. The filter includes a cube, a plurality of anchors and a plurality of locators. The cube can be arranged along a longitudinal geometric axis. The plurality of anchors branches off from the cube. Each anchor includes a hook that: (i) penetrates a wall of the blood vessel, (ii) can be spaced along the longitudinal geometric axis of the cube, and (iii) can be spaced radially from the longitudinal geometric axis to a first distance. The plurality of locators branch out from the cube. Each locator includes a base portion close to the cube, a tip portion that (i) can fit into the blood vessel wall, (ii) can be spaced along the longitudinal geometric axis of the cube, and (iii) can be spaced radially 25 from the longitudinal geometric axis at a second distance, which may be less than the first radial distance, and an intermediate portion that couples the base and the tip portion. The intermediate portion may include a first linear segment that extends from the base portion to a first length along a first geometric axis, which may be oblique to the longitudinal geometric axis, and a second linear segment that extends between the tip portion and the first portion at a second length, which may be greater than the first length, and along a second geometric axis, which may be oblique with respect to the longitudinal geometric axis and different from the first axis.
In another aspect of the various modalities, a filter is provided. The filter must be placed in a blood stream contained by a wall of a blood vessel. The filter includes a cube that extends along a longitudinal geometric axis and at least one first element with a first and a second, generally linear, segment. The filter further includes at least a second element having a generally linear third and fourth segments. The first segment defines a portion of a first cone when the first segment rotates about the longitudinal geometric axis. The second segment defines a cylinder when the second segment rotates about the longitudinal geometric axis. The third and fourth segments define the respective portions of a third and fourth cones, when each of the segments rotates about the longitudinal geometric axis. At least one of the third and fourth segments has a hook portion that penetrates the wall of a blood vessel.
In yet another aspect of the various modalities, a blood filter is provided to be placed in a blood stream contained by a wall of a blood vessel. The filter includes a cube, at least one anchor and a plurality of locators. The cube can be arranged along a longitudinal geometric axis that generally extends parallel to the blood flow. The at least one anchor includes a hook that penetrates the vessel wall. The at least one anchor defines a generator of a first conical shape around a longitudinal geometric axis. The first conical shape includes: (i) an apex arranged close to the cube, each anchor (ii) can be spaced along the longitudinal geometric axis of the cube, and (iii) can be spaced radially from the longitudinal geometric axis at a first distance. The plurality of locators branch off from the cube and define a first truncated cone having a geometric centroid along the longitudinal geometric axis.
In another aspect, a filter is provided. The filter can be placed in a blood stream contained by a wall of a blood vessel. O
The filter includes a cube, a plurality of anchors, and a plurality of locators. The cube can be arranged along a longitudinal geometric axis. The plurality of anchors branches off from the cube. Each anchor can include a hook that (i) penetrates a wall of the blood vessel, (ii) can be spaced along the longitudinal geometric axis of the cube, and (iii) can be spaced radially from the longitudinal geometric axis to a first distance. The plurality of locators branch out from the cube. Each locator includes a base portion that extends in an arc from the hub. The base portion has a radius of curvature on a transverse geometric axis 10 located at a second distance, generally radial from the longitudinal geometric axis. Each locator f has an end contiguous to the vessel wall. A portion of the tip closest to the cube can be spaced a third distance along the longitudinal axis of the cube and spaced a fourth radial distance from the longitudinal axis, the fourth radial distance being less than the third distance.
The various embodiments described above may also include radio-opaque material as part of the hub filter. In addition, the various modalities described above may also include a bioactive agent incorporated into the filter or as a part of the filter.
The various modalities also provide a method for centralizing a blood filtering device within a blood vessel having a plurality of locators that extend from a cube in order to define a first volume and a plurality of anchors that extend to 25 from the cube to define a second volume. The method can be obtained by placing more than 15 percent of the second volume in the first volume, and by fitting a hook provided over each locator to a wall of the blood vessel.
The various modalities also provide a blood filter 30 with different types and configurations of hooks and anchors in different longitudinal positions along a longitudinal geometric axis of the filter, in order to solve the potential problems with insufficient anchoring and subsequent caudal or cranial movement. In one aspect, the various modalities provide the blood filter with penetration limiters associated with the filter anchors and hooks to limit the penetration through the vessel wall. In one aspect, the various modalities also provide a blood vessel filter that is formed by laser cutting a metal tube. In one embodiment, a filter to be placed in a blood stream through a vessel comprises a cube arranged along a longitudinal geometric axis, a plurality of anchoring elements extending from the cube, each anchoring element including an extension cranial or a caudal extension at a distal end thereof, at least one distal end of the anchoring element being spaced from the cube in each of between a first, second and third distance along the longitudinal geometric axis, and a plurality of locating elements, each locating element extending from the hub between an adjacent pair of anchoring elements.
The various modalities also provide a method of preparing a blood filter for insertion into a vessel of the body, including folding / positioning the filter in a compact and small profile, in order to provide space for the filter hooks and anchors to be housed. , and also prevent the filter hooks and anchors from interfering with the loading and / or releasing of the blood filter.
In one embodiment, a method of preparing the filter for release into a body vessel, the filter having six anchor elements comprising a first, second, third, fourth, fifth and sixth anchor elements arranged successively counterclockwise on a cube circumference when viewed from the distal ends of the anchoring element, the filter further having six locating elements comprising a first, second, third, fourth, fifth and sixth locating elements arranged successively counterclockwise on a cube circumference when seen from the distal ends of the anchor element, it includes: (i) the limitation of the anchor elements in a deformed configuration; (ii) positioning a length of the first locating element nearest clockwise from the first anchoring element behind the first anchoring element and the second anchoring element such that a distal end of the first locating element extends between the second anchor element and the third anchor element; (iii) positioning a length of the second locator element behind the second anchor element and the third anchor element such that a distal end of the second locator element extends between the third anchor element and the fourth anchor element, (iv) the positioning of a length of the third locator element behind the third anchor element and the fourth anchor element in such a way that a distal end of the third locator element extends between the fourth anchor element and the fifth anchor element. anchoring; (v) placing a length of the fourth locator element behind the fourth anchor element and the fifth anchor element such that a distal end of the fourth locator element extends between the fifth anchor element and the sixth anchor element, (vi) the positioning of an extension of the fifth locator element behind the fifth anchor element and the sixth anchor element such that a distal end of the fifth locator element extends between the sixth anchor element and the first anchor element, (vii) positioning a length of the sixth locator element behind the sixth anchor element and the first anchor element such that a distal end of the sixth locator element extends between the first anchor element and the second anchor element anchoring, (viii) checking whether the anchoring elements with flow extensions are involved by the anchoring elements prayer with cranial extensions; and (ix) dragging the filter to a release sheath.
In one embodiment, a method of preparing the filter for release into a vessel in the body, the filter comprising N anchoring elements extended distally from a cube, the anchoring elements arranged and numbered successively counterclockwise on a cube circumference when viewed from a distal filter end, each anchor element including either a cranial extension or a caudal extension at its distal end, and the N locating elements extended distally from the cube, the locating elements arranged and numbered successively counterclockwise over a circumference of the cube when viewed from the distal end of the filter, each locator element extended from the cube between an adjacent pair of anchoring elements arranged in such a way that the locator element is not positioned immediately adjacent clockwise to anchor n, where N is greater than 5 , includes: (i) limiting the anchoring elements to a deformed configuration; (ii) positioning a length of the locator element 1 behind the anchor element 1 and the anchor element 2 such that a distal end of the locator element 1 extends between the anchor element 2 and the anchor element 3, (iii) the repetition of step (ii) for the locating elements 2, 3 ,. . ., and N-2; (iv) the positioning of a length of the locating element N-1 behind the anchoring element N-1 and the anchoring element N such that a distal end of the locating element N-1 extends between the anchoring element Neo element anchoring 1; (v) positioning a length of the locator element N behind the anchor element N and the anchor element 1 such that a distal end of the locator element N extends between the anchor element 1 and the anchor element 2; (vi) checking whether the anchoring elements with tail extensions are involved by the anchoring elements with cranial extensions; and (vii) dragging the filter to a release sheath.
These and other modalities, characteristics and advantages will become more apparent to those skilled in the art when taken with reference to the more detailed description of the present invention below, together with the attached drawings, which are briefly described below. BRIEF DESCRIPTION OF THE DRAWINGS
The attached drawings, which are incorporated into this document and form part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description 5 above and the detailed description below, serve to explain the characteristics of the present invention. .
Figure 1 is a perspective view from the top to the bottom of a preferred embodiment of the blood filter.
Figure 2 is a perspective view from the base to the top of the embodiment of figure 1.
Figure 3 is a plan view of the filter of figure 1 on the longitudinal geometric axis A. 4b
Figure 4A is a side view of the filter seen along line 4A-4A in figure 3.
Figure 4B is a side view of an arm or locating element of the filter of figure 1.
Figure 5A is a side view of the filter seen along the line 5A-5A of figure 3.
Figure 5B is a side view of a filter locator element. 20 of figure 1.
Figure 5C is a side view of an alternative location arrangement having a retaining element disposed on the locator.
Figure 5D is a side view of another locator arrangement having a support element in order to reduce or prevent the penetration of a blood vessel wall by the locator.
Figure 6 is an enlarged side view of a hook from the anchor to the filter of Figure 1.
Figure 7 is a shaded perspective view of a volume generated by the locating element on the outside of a cube, as it rotates or sweeps the entire longitudinal geometric axis A.
Figure 8 is a shaded perspective view of a volume generated by the anchor element outside the cube as the anchor element rotates or sweeps the entire longitudinal geometric axis A.
Figure 9 illustrates the volume of the anchor element visible outside the volume of the locator element.
Figures 10 to 14 illustrate yet another preferred embodiment having a recovery hook portion.
Figure 15 is a perspective view of a blood filter embodiment.
Figure 16A is an enlarged view of a cranial extension of the blood filter of Figure 15.
Figures 16B and C are representations of exemplary cranial extensions.
Figure 17A is an enlarged view of a blood filter flow extension of Figure 15.
Figures 17B and C are representations of exemplary flow extensions.
Figure 18 is a different perspective view of the blood filter in Figure 15.
Figure 19 is another perspective view of the blood filter in Figure 15, illustrating its parameters.
Figure 20 is a perspective view of an embodiment of a recovery element for the blood filter of Figure 15.
Figures 21A and B are enlarged views of an alternative embodiment of a recovery element for the blood filter of figure 15.
Fig. 22 is an enlarged view of a portion of the blood filter of Fig. 15 when it is prepared for loading and releasing.
Fig. 23 is an enlarged view of a portion of the blood filter of Fig. 15 in another stage of preparation for loading and releasing.
Figure 24 is an enlarged view of a portion of the blood filter of Figure 15 in another stage of preparation for loading and releasing.
Figure 25 is a schematic view of the filter from a distal end in another stage of preparation for loading and releasing.
Fig. 26 is an enlarged view of a portion of the blood filter of Fig. 15 in another stage of preparation for loading and releasing. DETAILED DESCRIPTION
The various modalities will be described in detail with reference to the attached drawings. Whenever possible, the same reference numbers will be used in all drawings to refer to the same or similar parts.
As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate an adequate dimensional tolerance that allows part or set of components to function for their intended purpose, as described in this document. In addition, as used herein, the terms "patient", "host" or "person" refer to any human or animal and are not intended to limit systems or methods to human use, although the use of the present invention in a human patient it represents a preferred modality.
Figures 1 to 14 illustrate preferred embodiments. With reference to figure 1, a filter 100 is shown in a perspective view. The filter 100 includes a hub 10, a locator element 20, and an anchor element 30 that has a hook 40. The filter 100 can be made of a plurality of elongated wires, preferably of metal, such as, for example, Elgiloy, and, more preferably, from a superset with an elastic form memory, such as Nitinol. The wires are held together at the end of the filter by means of a hub 10 using an appropriate connection technique, such as, for example, welding, laser welding, plasma welding or connected together. Preferably, the wires are plasma welded. As used herein, "wire" refers to any elongated element of narrow cross section, including rods, bars, tubes, wires and narrow sections cut from thin sheets, and is not intended to limit the scope of this invention to elongated elements of circular cross section, cut from a stock or wire fabrication, according to a particular method of metal forming.
The locator element 20 has a proximal locator end and a distal locator end 20D. Likewise, the anchor element 30 has a proximal anchor end 30P and a distal anchor end 30D. The distal anchor end 30D can be provided, as shown in figure 6, with a hook 40.
With reference to figures 4A and 4B, the locator element 30 can be provided with a plurality of locator segments, preferably between 3 and 6 segments and, more preferably, four locator segments LS1, LS2, LS3, LS4. The first locating segment LS1 can be a curved portion extending out of the cube in a first direction along the longitudinal geometric axis A. In one embodiment, the second locating segment LS2 generally extends linearly along a second axis 110; the third locator segment LS3 generally extends linearly along a third axis 120; and the fourth locator segment LS4 generally extends linearly along a fourth axis 130. In a preferred embodiment, the various axes A, 110, 120, 130 and 140 are distinct from each other, in the sense that each which can intersect with each other, but none of them is substantially collinear with each other.
The locating segment LS2 can be distinguished from the locating segment LS3 by virtue of a joint or fold LJ1. The locating segment LS3 can be distinguished from the locating segment LS4 through a joint or fold LJ1 or LJ2. Joint or fold LJ1 or LJ2 can be seen as a place formed by the intersection of the segments that define a striped portion that connects any two segments.
Locators 20 can range from 3 to 12 locators. The filter modality illustrated in figure 4A includes six locators that are generally spaced at equal angles around the A axis. In the modality illustrated in figure 4B, the locating segment LS1 extends through an arc with a radius of curvature R1 whose center can be located along a geometric axis orthogonal to axis A at a transverse radial distance ds and also at a longitudinal distance L4 as measured from a terminal surface 12 of the cube 10 along a geometric axis in general parallel to the longitudinal geometric axis A. The locating segment LS2 extends along the axis 110 so as to form a first angle θi with respect to the longitudinal geometric axis A, while the locating segment LS3 extends along the axis 120 in order to form the second angle θ2. As shown in figure 4B, the first locator joint or fold LJ1 can be located on a longitudinal length L1 generally parallel to axis A from the end surface 12. The first locator joint or fold LJ1 can still be located approximately at a half distance "d√ 'from an A axis on a geometric axis generally orthogonal to the A axis, as shown in figure 4A, the distance di being the distance between the internal surfaces of the respective diametrically arranged locators 20. The second locator joint LJ2 can be located over a longitudinal length L2 generally parallel to axis A. The second locator joint LJ2 can be located at a distance of approximately half a diameter "d2" from axis A. A distance d2 is the distance between the outermost surface of the fourth segment LS4 of the respective diametrically arranged locators 20. The thickness of the locating element 20 is you. When the locator element 20 is a wire of circular cross section, the thickness ti of the locator 20 can be the diameter of the wire.
A range of values can be used for the dimensional parameters mentioned above, in order to provide the locating elements that will locate the filter inside the vein or vessel in which the filter must be applied in a way to position the LS4 segment approximately parallel to the walls. of the vein or vessel and provides sufficient lateral force against the vein or vessel wall to centralize the filter, but not so much as to cause injury to the wall. For example, a filter intended to be placed in a narrow vein or vessel, such as in a human or canine baby's vena cava, may have smaller dimensions L1f l_2, l_3, L4, LS1, LS2, LS3, LS4, di and d2 so that the positioning elements can be implanted enough to perform the positioning and filtering functions, than a filter intended to be placed in a large vein or vessel, such as the vena cava or other vessel of an adult human . In an exemplary embodiment suitable for a human adult vena cava filter, when the filter is at the patient's temperature and not forced, the radius of curvature Ri is about 0.05 centimeter (0.02 inch) at about 0.25 centimeter (0.1 inch), with the center of radius Ri being located at a distance d3 from axis A of about 0.25 cm (0.1 inch) and an L4 length of about 0.51 centimeters (0.2 inches), the Li length is about 0.76 centimeters (0.3 inches); the length L2 is about 2.29 centimeters (0.9 inches), the distance di (measured for the internal surfaces of the diametrically arranged locators 20) is about 2.03 centimeters (0.8 inches), the distance d2 is about 3.81 centimeters (1.5 inches, the first angle 0i is about 58 degrees, the second angle 02 is about 22 degrees; and the thickness ti of the locator is about 0.03 centimeters (0.013 It should be noted that the values presented in this document are approximate, representing a dimension within a range of dimensions suitable for the particular modality illustrated in the figures, and that any suitable values can be used, provided that these values allow the filter works as intended in a person's blood vessel.
With reference to figures 5A and 5B, the hub 10 can be provided with an internal cylindrical opening with a diameter of about twice the distance d3. Each of the plurality of anchor elements 30 can be provided with a first anchor segment LA1, a portion of which is arranged within the hub 10, connected to a second anchor segment LA2 by means of a first anchor joint or bend. AJ1, which can be connected to a third anchor segment LA3 through a second joint or anchor bend AJ2. The third anchor segment LA3 can be connected to the hook 40 via a third joint or anchor bend AJ3. The first anchor segment LA1 extends obliquely to axis A. The second anchor segment LA2 extends along axis 130 oblique to axis A above an angle θ3 to the longitudinal geometric axis A. The third segment of anchor LA3 extends along the oblique axis 140 with respect to the longitudinal geometric axis A at an angle 04. The second joint or anchoring bend AJ2 can be located at a sixth longitudinal distance L6, as measured on a generally parallel geometric axis to axis A from the terminal surface 12 of cube 10 and about one half of the fourth distance d4, as measured between the generally diametric endpoints of the two anchors 30 on an axis generally orthogonal to the axis A. The third anchor joint AJ3 can be located at a seventh longitudinal distance l_7, as measured along an axis generally parallel to axis A and at a transverse distance of about half a dis d7, as measured on a geometric axis orthogonal to the A axis between the internal surfaces of two anchors in general diameters 30. The thickness of the anchor element 30 is nominally t2. When the anchor element 30 is a wire of circular cross section, the thickness t2 of the anchor 30 can be the diameter of the wire. As shown in figure 5B, the hook 40 can be contiguous to a plane located at a longitudinal distance L10, as measured for the terminal surface 12 of the hub 10. The hook 40 can be characterized by a radius of curvature R2, in its expanded configuration at a suitable temperature, for example, the ambient temperature or the internal temperature of a person. The center of hook curvature R2 can be located at a distance Lu, as measured along an axis generally parallel to axis A 40 from the terminal surface 12 of hub 10 and at a mid distance d6, as measured between two Generally diametral hooks. The ends 40T of the respective diametral hooks 40 can be located at a longitudinal distance LI2 (which can be approximately equal to the longitudinal distance L7 for the third anchoring joint AJ3) and at a half distance d7 between the diametral hooks 40.
The range of values can be used for the dimensional parameters mentioned above, in order to provide the anchoring elements that will locate and anchor the filter within the vein or vessel to which the filter must be applied in order to position the hooks 40 in contact with the walls of the vein or vessel and provide sufficient lateral force against the vein or vessel wall to ensure that the hooks engage the wall, but not so tightly as to cause damage to the wall. For example, a filter intended to be placed in a narrow vein or vessel, such as in a child's or dog's vena cava, may be smaller in size so that the anchoring elements can be implanted enough to perform the functions of positioning, anchoring and filtering, than a filter intended to be placed in a large vein or vessel, such as the vena cava or other vessel of an adult. In an exemplary embodiment suitable for a human adult vena cava filter, when the filter is at the patient's temperature and not forced, the longitudinal distance L8 is about 0.05 centimeter (0.02 inch); l_9 is about 0.51 centimeter (0.2 inch); Lio is about 3.30 centimeters (1.3 inches); Lu is about 3.05 centimeters (1.2 inches); d8 is about 3.81 centimeters (1.5 inches); d7 is about 4.06 centimeters (1.6 inches); d8 is about 0.03 centimeters (0.01 inches); d9 is between 3.81 and 4.06 centimeters (1.5 and 1.6 inches); LI2 is about 3.05 centimeters (1.2 inches); the radius of curvature R2 is about 0.08 centimeters (0.03 inches); and the thickness t2 of the anchor is about 0.03 centimeter (0.013 inch). More preferably, a very small radius of curvature R3 can characterize the anchoring joint or bend AJ2, whose radius R3 can be about 0.03 cm (0.01 inch).
In the event that additional filter retention may be desired, an anchor element may be attached to the locator. An arrangement is shown exemplarily in figure 5C, in which a hook 22 can be attached to the locator near the tip portion. In this arrangement, both the tip portion and the hook 22 are configured so that the locator does not penetrate through the blood vessel wall, by forming a lock region 22a defined by both the locator tip and the hook 22. Another arrangement may be by coupling or forming a hook in the same configuration as the hook 40 for the anchoring elements. In yet another arrangement, shown here in figure 5D, in which it may not be desirable to use a hook, one or more locking elements 24 can be provided on the locator in any suitable locations. As shown in figure 5D, the locking element 24 is in the form of a truncated cone coupled to the locator. However, the locking element 24 can be of any configuration, as long as the element 24 reduces or prevents the locator from penetrating through the blood vessel wall. In yet another arrangement, the hook 22 (or hook 40) can be used in combination with the locking element 24, such as, for example, a hook 22 coupled to a first locator, a hook 40 coupled to a second locator , a locking element 24 on a third locator, a combination of hook 22 and locking element 24 on a fourth locator, a combination of hook 40 and locking element 24 on a fifth locator.
With reference to figure 6, the hook 40 can be provided with a proximal hook portion 40P and a distal hook portion 40D on which a sharp tip 40T is provided. The hook 40 can be formed to have a thickness t3. When the hook 40 is formed from a wire having a generally circular cross-section, the thickness t3 can generally be equal to the outer diameter of the wire. In one embodiment, the thickness of hook t3 is approximately 0.5 to approximately 0.8 with respect to anchor thickness t2. The wire can be configured to follow a radius of curvature R2, the center of which is a longitudinal distance Lu and a radial distance dg when the filter is at a person's temperature, as shown above. The tip 40T may be provided with a generally planar surface 40D, the length of which may be approximately equal to the length hi. Tip 40T can be located at a distance h2 from a tangential plane to the curved portion 40S.
With reference to figure 7, the locators 20 are illustrated as being limited by a first composite surface, having a revolution SR1 around axis A by rotating one of the locators 20 around axis A by 360 degrees. The first composite surface, having an SR1 revolution, includes a portion of a truncated hyperboloid H, a first truncated cone F1, a second truncated cone F2, and a cylindrical surface C1. With reference to figure 8, anchors 30 are illustrated as being limited by a second composite surface, having an SR2 revolution around axis A, by rotating one of anchors 30 on axis A by 360 degrees. The second composite surface, with the revolution SR2 defined by anchors 30, includes a third, fourth and fifth truncated cones F3, F4 and F5, respectively.
It is believed that several design parameters allow the preferred modalities to achieve several advantages over known filters. The various advantages include, for example, less migration of filter 100 once installed, greater volume of filter, and better concentricity with respect to the inner wall of the blood vessel. A number of design parameters can be adjusted in order to obtain the performance and filter adjustment characteristics, including, for example, the ratio between the volume V1 defined by the first surface of revolution SR1 and the volume V2 defined by the second surface of rotation. revolution SR2, which can be at least 0.92, preferably about 1.0, and most preferably about 0.99. In addition, about 15% or more of volume V2 can be surrounded by volume Vi, preferably at least 25% of volume V2 can be surrounded by volume Vi, and more preferably about 35% of volume V2 can be surrounded by volume Vi so that the portion of volume V2 that is not surrounded by volume Vi (that is, volume Vi outside the first volume Vi), shown as volume V3 in figure 9, is about 1.02 cubic centimeters (0 , 4 cubic inches). Furthermore, it has been found that, in the preferred embodiments, once the cross-sectional area of the hook is increased, the filter 100 tends to resist displacement when installed in a simulated blood vessel.
Similarly, when the radius of curvature R2 is smaller, while keeping the other parameters generally constant, the resistance to displacement in a simulated blood vessel is greater.
The filter material can be of any suitable biocompatible material, such as, for example, a polymer, a polymer with memory, a metal with memory, a material with thermal memory, a metal, a metal alloy, or ceramic . Preferably, the material may be Elgiloy, and more preferably Nitinol, which is a thermal alloy with shape memory.
The use of a shape memory material, such as Nitinol, for the locating and anchoring elements facilitates the deformation of the filter in the internal radial direction from its normally expanded configuration (that is, without limitations) to its longitudinal geometric axis in a deformed configuration for insertion into a body vessel. The properties of Nitinol allow the filter elements to withstand enormous deformations (for example, eight times more than stainless steel) without this having any effect on the ability of the filter to recover its predetermined shape. This is due to the crystal phase transitions between the rigid austenite and the more docile martensite. This phenomenon allows the implant to be loaded in a sheath with a very small diameter for release, which significantly reduces trauma and complications to the insertion site.
The transition between the martensitic and austenitic forms of the material can be achieved by increasing or decreasing the deformation of the material above and below the transition tensile level, while the material remains above the transition temperature range, specifically Af. This is particularly important in the case of hooks, since they can be significantly deformed (hence becoming martensitic), while the filter is challenged by clots. The super elastic properties will allow the hooks to vote to assume their intended shape, as soon as the loading is released (for example, the clot breaks).
Hooks can be retrieved from the wall of the inferior vena cava ("IVC") during filter removal when a longitudinal force is applied to the cube 10 in the direction of the BF cube (ie, to the filter cube 10). Under this concentrated pull, the hooks will stretch and transition to the martensitic state, thus becoming superelastic. Therefore, the hooks 40 are designed to bend towards a substantially straight configuration when a specific hook migration force is applied and resiliently return to their original shape so the hook migration force is removed.
Alternatively, a temperature reduction below the Af temperature can be applied to the memory material in such a way as to cause a change in the crystalline phase of the material in order to make the material malleable during filter loading or recovery. Various techniques can be used in order to cause a change in the crystalline phase, such as, for example, a cold saline solution, a low temperature fluid or a thermal conductor.
Due to the characteristics of the thermal material with shape memory, the locating and anchoring elements can be cooled below the martensitic to austenitic transition temperature, and then stretched and maintained in a straight, deformed shape that can pass through a length of pipe thin plastic with an internal diameter of about 2 millimeters (mm), for example, a # 8 french catheter. In its high temperature form (as in a mammalian body), filter 10 recovers a preformed filtration form, as shown in figure 1. Alternatively, the locating and / or anchoring elements can be made of spring metal that can be stretched and compressed into a catheter or tube and diverge into the filter shape of figure 1 when the tube is removed.
The unfolded shapes and configurations of the filter elements can be defined (printed with a memory form) by annealing the elements at high temperature (for example, about 500 ° C), keeping them in the desired shape. Thereafter, whenever
The filter is in the austenitic form (that is, at a temperature above the martensitic to austenitic transition temperature or at an Af temperature), the elements return to the memory form. Exemplary methods for defining the high temperature form of the filters are presented in US Patent No. 4,425,908, the content of which is incorporated into this document as a reference in its entirety.
In the form of high temperature material with shape memory, the filter has a first and second filter basket or sieve in general coaxial, each filter basket being generally symmetrical about the longitudinal geometric axis of the filter, both being concave filter baskets in relation to the filter leading end.
The screen V2 formed by the anchor elements 30 becomes the primary filter and can be up to twelve anchor elements circumferentially spaced 30. Six anchor elements 30 are shown in the manner illustrated in the figures. The anchoring elements can be of equal length, but they can be of different sizes, so that the hooks 40 at the ends of the wires fit within a catheter, without becoming interconnected. The anchoring elements 30, in their expanded configuration illustrated in figure 1 (that is, without limitations in the form of high temperature), are at a smooth angle with respect to the vessel wall, preferably within a range of ten to forty-six. five degrees, while hooks 40 penetrate the vessel wall in order to anchor the filter against movement. The anchoring elements 30 are radially displaced with respect to the locating elements 20 and can be positioned radially halfway between the locating elements 20 and can also be circumferentially spaced at sixty degrees of arc, as shown in figure 3. The locating elements 20 form the screen Vv Thus, the combined filter screens V2 and Vi can provide a wire positioned radially over the cube 10, as in all thirty degrees of arc, to a maximum divergence of the filter sections. With reference to the direction of blood flow BF shown by the arrow of figures 2 and 4A, in the illustrated embodiment, the filter section V2 forms a truncated cone in the direction of the cube 10 of the filter 100 while the filter section Vi forms a concave sieve so general type of truncated cone, with its geometric center near the terminal end 12 of the cube 10. In the preferred embodiments, the volume Vi of the surface SR1 can be between about 0.76 and about 2.79 cubic centimeters (between about 0.3 and about 1.1 cubic inches), preferably about 1.78 cubic centimeters (0.7 cubic inches) and the volume V2 of the SR2 surface can be between about 0.76 and about 2, 79 cubic centimeters (between about 0.3 and about 1.1 cubic inches), preferably about 1.78 cubic centimeters (0.7 cubic inches).
The structure of the hooks 40 is believed to be important in resistance to migration of the filter when installed, allowing its removal from the blood vessel after installation. As in the case of hooks formed on the anchoring elements of known permanent vena cava filters, these hooks 40 penetrate the vessel wall when the filter 100 expands to anchor the filter in place and prevent the migration of the filter longitudinally within the vessel in any direction. However, when the hooks 40 are implanted and later covered by the endothelium layer, they and the filter can be removed without the risk of significant injury or rupture of the vena cava. Minor injuries to the vessel wall due to hook removal, such as damage to the endothelial layer or perforation of the local vena cava wall are acceptable.
In order to allow the safe removal of the filter, the junction section 40S can be considerably reduced in cross section in relation to the thickness t2 or in cross section of the anchor element 30 and the rest of the hook 40. The junction section 40S can be dimensioned in such a way that it becomes sufficiently rigid when the anchoring elements 30 expand in order to allow the hook 40 to penetrate the vena cava wall. However, when the hook is to be removed from the vessel wall, the force of removal in the direction of the BF blood flow will flex the junction section 40S so that the tip of the 40T hook moves towards a position parallel to the axis A (that is, the hook stretches). With the hooks then stretched, the filter can be removed without tearing the vessel wall, leaving only small holes. In one embodiment, the anchor element 30 has a cross-sectional area of about 0.08387 square centimeters (0.00013 square inches), and the hook 40, particularly the curved junction section 40S has a cross-sectional area of about 0.055483 square centimeters (0.000086 square inches).
With reference to figure 6, it should be noted that the entire hook 40 can be formed with a cross section t3 in its entire length that is less than that of the locating elements 20 (which have a thickness ti) or that of the elements anchor 30 (which have a thickness t2). As a result, an axial pulling force will tend to stretch the hook 40 along its entire length. It is believed that this elasticity in the hook structure will prevent the hook from tearing the vessel wall during its removal.
As previously indicated, although it is possible that the filter can be made from ductile metal alloys, such as stainless steel, titanium, or Elgiloy, it is preferable to produce the same from Nitinol. Nitinol is a low modulus material that allows the locating and anchoring elements of the device 100 to be designed so as to present low contact forces and pressures and still achieve a sufficient anchoring force to resist the migration of the device. The force necessary to cause the hooks 40 to open can be modulated to the total force necessary to resist the migration of the filter. This is achieved by changing the cross-sectional area or the geometry of the hooks, or by selecting materials, as discussed above.
In addition to temperature sensitivity, when in the high temperature austenitic state, Nitinol is also subject to a tensile sensitivity that can cause the material to undergo a transformation from austenitic phase to the martensitic state, while the material temperature remains above the transition temperature. When reducing the cross-sectional area of a portion or the totality of the hooks 40 in relation to the anchoring elements 30 or the locating elements, the traction will be concentrated in the areas of reduced cross-section when the longitudinal force is applied to the hub 10 in the direction of hub BF (i.e., to hub 10 of the filter), such as to remove the filter. Under this concentrated traction, the reduced cross-sectional portions of the hooks will be able to transition to the martensitic state, thus becoming elastic in order to stretch. Thus, hooks 40, whether made of Nitinol, Elgiloy, a metal or plastic spring, are designed to bend to a substantially straight configuration when a specific hook migration force is applied and to return to its original shape as soon as the hook migration force is removed.
The force or traction that is necessary to deform the hooks 40 can be correlated to the force applied to each hook of the device when it is completely blocked and the arterial pressure in the vessel can reach 50 millimeters of mercury (mm Hg) in a test bench. The test bench (not shown) can be configured to have a tube length (with several internal diameters) in order to allow a filter to be properly attached to it. The tube is connected to another tube having a terminal end exposed to the ambient atmosphere and marked with gradations in order to indicate the amount of pressure differential through the filter, which is related to the force that is applied to each locator of the filter 100. This strength is approximately at least 70 grams at each anchor of a six-anchor device for at least 50 mm Hg of differential pressure in a 28 mm vessel. The total migration resistance strength desired for the filter is believed to be approximately 420 grams for the modality of a vena cava filter for a human adult, and more anchoring elements 30 with hooks 40 can be added in order to decrease the maximum migration force for each hook. The loading on the filter would be proportionally less in vessels of smaller diameter. Preferably, the hooks 40 function as an anchoring mechanism at a predetermined filter migration resistance force within a range of about 10 mm Hg to about 150 to 200 mm Hg. Having maintained its geometry at a predetermined filter migration resistance force within that range, the hook 40 preferably begins to deform in response to a greater force applied in the direction of the hub, that is, at the rear end of the TE filter with blood flow, and the release of a force substantially less than that which could cause damage to the tissue of the vessel. It is the ability of the hook to stretch a little that allows the safe removal of filters of the preferred modality from the vessel wall.
After filter 100 has remained in place within a blood vessel for a period of time greater than two weeks, the endothelium layer will grow along hooks 40. However, since these hooks 40, when subjected to a withdrawal force towards the hub (ie towards the rear end TE), become substantially straight sections of wire oriented at a small angle to the vessel wall, the filter can be removed leaving only six pin point lesions on the surface of the endothelium. To achieve this effect, a catheter, such as, for example, the unit described and shown in US Patent No. 6 156 055, which is incorporated by reference to this document, or a similar recovery unit is inserted over the hub 10 and in place with the locating elements 20. While the hub 10 remains stationary, the catheter can be moved downwards, forcing the locating elements 20 to bend in the direction of the A axis, and then to engage on the anchoring elements 30 and forcing them downwards, thereby removing the hooks 40 from the endothelium layer. Then, the cube 10 can be dragged into the catheter in order to deform the entire filter 100 inside the catheter. When the filter is formed from a material with shape memory, a refrigerant fluid (for example, a refrigerated saline solution) can be passed through the catheter during these steps in order to help deform the filter.
The main purpose of the hooks 40 is to ensure that the filter does not migrate during normal respiratory function or in the case of massive pulmonary embolism. Normal pressures of the inferior vena cava (CVI) are believed to be between about 2 mm Hg and about 8 mm Hg. An obstructed IVC vein can potentially pressurize 35 mm Hg below the occlusion. In order to ensure filter stability, a pressure drop of 50 mm Hg through the filter can therefore be chosen as the design criteria for the filter migration resistance strength for the removable filter 100. When a pressure of removal is applied to the filter that is greater than at least 50 mm Hg, the hooks 40 will deform and release from the vessel wall. The pressure required to deform the hooks can be forcibly converted using the following calculations.
Since 51.76 mm Hg = 1.0 pound per square inch (psi), 50 mm Hg = 0.9668 psi
For a 28 mm vena cava: A = π / 4 (28) 2 mm2 = 615.4 mm2 = 0.9539 inches2
The migration force is calculated by: P = F / AF = PxA 0.9668 psi x 0.9539 inch2 = 0.9223 pound = 418.7 grams It should be noted that as the diameter of the vena cava increases, the same is true of the force necessary to withstand at least 50 mm Hg of pressure. Depending on the number of filter hooks, the strength of each can be calculated. For a device that has six hooks:
Hook Force = Resistance to Filter Migration / Number of Hooks = 418.7 / 6 = 69.7 grams
In other words, each hook must be able to withstand at least about 70 grams of force for the filter 100 to withstand at least a 50 mm Hg pressure gradient in a 28 mm vessel.
In order to avoid excessive vessel trauma, each individual hook needs to be relatively weak. By balancing the number of hooks and the individual hook strength, minimal vessel damage can be achieved, while maintaining the pressure gradient criteria of at least 50 mm Hg, or some other predetermined pressure gradient criteria within a range of 10 mm Hg to 150 mm Hg.
With reference to figure 4A, the anchor elements 30 can be angled out from the adjacent joint or anchor bend AJ1, but spaced from the outer end of each anchor element 30. When the anchor elements 30 are released from compression in a catheter or other tube in a body vessel, this curve in each anchor element ensures that the hooks 40 are, in fact, spring loaded in the tube and that they do not cross as they are unfolded from the tube . Since the anchors 30 are angled out from the shoulders 30, the hooks 40 are quickly unfolded outwardly as the insertion tube is removed.
In another embodiment, bioactive agents can be incorporated into the blood filter, such as, for example, by means of a coating on parts of the filter, or structures dissolved on, inside or attached to the filter. A bioactive agent can be included as part of the filter, in order to treat or prevent other conditions (such as infection or inflammation) associated with the filter, or to treat other conditions not related to the filter itself. In more specific terms, bioactive agents can include, but are not limited to: pharmaceutical agents, such as, for example, antiproliferative / antimitotic agents, including natural products, such as vinca alkaloids (ie vinblastine, vincristine and vinorelbine), pacli-taxel, epidipodophyllotoxins (ie etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycin, plicamycin (mitramicin) and mitomycin, the enzymes (L-asparaginase, which systematically metabolizes asparagine and deprives cells that are unable to synthesize their own asparagine); antiplatelet agents, such as G (GP) 11b / IIla inhibitors and vitronectin receptor antagonists; antiproliferative / antimitotic alkylating agents, such as nitrogen mustards (meclorethamine, cyclophosphamide and the like, melphalan, chlorambucil), and ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates - busulfan , nirtosoureas (carmustine (BCNU) and analogues, streptozoein), and trainees - dacarbazinin (DTIC); antiproliferative / antimitotic anabolites, such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine and cytarabine), purine analogs and related inhibitors (a mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine (a Cladribine}); platinum coordination complexes (carboplatin, cisplatin), procarbazine, hydroxyurea, mitotane, aminoglutetimide; hormones (estrogen, for example); anticoagulants (heparin, synthetic heparin salts and other thrombin inhibitors), fibrinolytics (such as plasminogen activating tissue, streptokinase and uroquinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; anti-migratory agents; antisecretory agents (for example, brevel-din); anti-inflammatory agents, such as adrenocortical steroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6.alpha - methylprednisolone, triamcinolone, betamethasone and dexamethasone), non-steroidal agents (derivatives of salicylic acid ie aspirin; derivatives of para-aminophenol, ie acetominophen; acetic acids of indole and indene (indomethacin, sulindac and etodalac), acetic acids of heteroaryl (a tolmetin, diclofenac and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid and meclophenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone and oxifentatrazone), a nabumetone, gold compounds (auranofin, aurothioglucose, sodium thiomalate gold); immunosuppressants: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), angiotensin receptor blockers; nitric oxide donors; antisense oligonucleotides and their combinations; cell cycle inhibitors, such as mTOR inhibitors and growth factor receptor signal transduction kinase inhibitors; the retenoids; cyclin / CDK inhibitors; the HMG coenzyme reductase inhibitors (statins), and protease inhibitors.
A filter release unit (not shown), such as, for example, the unit described in US Patent No. 6 258 026, which is incorporated by reference in this document, is adapted to provide filter 100 through from a catheter or delivery tube to a generally centralized position within a vessel of the body, as described in more detail in the aforementioned patent. Preferably, the delivery system may be the delivery system presented and described in US 2009/0318951 A1, which is incorporated herein by reference in its entirety in this application.
In one embodiment, a radio-opaque material can be incorporated into a portion of the filter, preferably the filter hub 10. As used herein, a radio-opaque material is any material that is machine-identifiable or radiographic equipment human-readable, while the material is within a mammalian body, such as, for example, but not by way of limitation, gold, tungsten, platinum, barium sulfate, or tantalum. The use of a radio-opaque material in the filter allows the doctor to locate the filter inside a person's blood vessel using radiographic equipment. The radio-opaque material can be in the form of an additional structure that is added to the cube, such as a cover, a glove, a wedge, a wire or solder included around or inside the cube assembly. Alternatively, the hub itself can be made of a radio-opaque alloy.
Instead of a cube 10, as in the embodiments described above, a recovery hook can be provided as part of the filter device 200, as in the embodiment shown in figure 10. The filter device 200 includes a cube 210 with a recovery hook 220. Hook 220 is configured to be used by a network device in order to retrieve a filter 200 from a person. With reference to figures 11 and 12, the recovery hook 220 can be formed as a monolithic element 230 with hub 210 or as a separate element connected to hub 210 by means of a suitable technique, such as, for example, EDM, laser welding , plasma welding, brazing, soldering, or bonding. In a preferred embodiment, element 230 may be a machined billet element with a blind hole 240 formed through a portion of hub 210. Hook portion 220 includes inclined surfaces 250 and 260, which is believed to be advantageous, as since they allow the filter 200 to be retrieved without attaching to the catheter opening due to a shifted inlet position of the filter 200. In other words, there may be circumstances during removal procedures in which the 300 axis of the element 230 is generally not parallel to or aligned with the longitudinal geometric axis of the catheter retrieval device. In such cases, the greater the retention force, it is believed that the greater the probability that the hook will be obstructed in the catheter inlet opening, thus complicating the filter recovery process. Due to ramps 250 and 260, it is believed that the connection or obstruction becomes substantially reduced. In particular, as shown in figures 13 and 14, the ramp 250 includes a radius of curvature R4 coupled to the flat portions 252 and 254. The flat portion 254 can be coupled to a hook portion 256 which has a radiused surface R6. As shown in figure 13, the flat portion 252 is coupled to another striped portion R7. It should be noted that the drawings provided in this document are made to scale with respect to all the parts illustrated in each drawing.
A range of values can be used for the aforementioned dimensional parameters in order to provide a recovery hook 230 that is capable of holding portions of the locating and anchoring elements 20 and 30 within the blind hole 240. For example, a filter smaller may have smaller dimensions, so that the recovery hook 230 does not present an improper blockage in the vein, than a filter intended to be placed in a large-caliber vein or vessels, such as an adult vena cava or other vessel . In addition, the recovery hook 230 can be made of or include radio-opaque material in order to allow a physician to locate the hook within a person using radiological equipment, such as to assist in fitting the hook to a recovery mechanism.
In a embodiment illustrated in figure 15, a filter 300 is laser cut from a metal tube and includes a hub 310, the locator element 320, and the anchor element 330. The locator element 320 includes an end of proximal locator 320P and a distal locator end 320D, similar to locator element 20 of figure 1. Likewise, anchor 330 includes a proximal anchor end 330P and a distal anchor end 330D. The distal anchor end 330D of each anchor element 330 includes an extension element. In the illustrated embodiment, four of the six anchor elements include a cranial extension 340 and two of the six anchor elements include a tail extension 350. In other embodiments, the extension elements can be distributed differently. For example, the number of anchor elements with cranial extension 340 may be less than or greater than four, and the number of anchor elements with tail extension 350 may be one, three, or more. Both the cranial extension 340 and the caudal extension 350 branch into a penetration element and a penetration limiter. The penetration element is designed to penetrate the vessel wall, while the penetration limiter is designed to limit the penetration of the penetration element.
Figure 16A shows an enlarged view of cranial extension 340 in figure 15. In an exemplary embodiment suitable for a human adult, the vena cava filter, when the filter is at the patient's temperature and not forced, the radius of curvature R2 is about 0.08 centimeter (0.03 inch), the hi length is about 0.05 centimeter (0.02 inch), the h2 length is about 0.10 centimeter (0.04 inch), the hs length is about 0.03 cm (0.01 inch), h4 length is about 0.18 cm (0.07 inch); the angle θ5 is about 46 degrees, the angle θ6 is approximately 15 degrees. It should be noted that the values presented in this document are approximate, representing a dimension within a range of dimensions suitable for the specific modality illustrated in the figures, and that any suitable values can be used, as long as the values allow the filter to work as intended in a person's blood vessel. The geometry and curvature of the cranial hook 342 will facilitate removal of the vessel, although it should be noted that the curvature can be several degrees less than the substantially straight. With reference to the pressure required to deform cranial hook 342 using the calculations above, since the number of cranial hooks 342 on filter 300 is four, the required hook force is about 104.7 grams (418.7 / 4 ), which means that each hook must be minimally capable of withstanding approximately 105 grams of force for the filter to withstand at least 50 mm Hg of pressure gradient in a 28 mm vessel.
An illustration of an exemplary cranial extension is shown in figures 16B and 16C. Cranial extension 340 'forks from a base 346' on a cranial hook 342 'and a cranial limiter 344'. The base 346 'has a width greater than that of the anchor element 330' from which it extends in the embodiment shown in order to provide a greater width for both the cranial hook 342 'and the cranial limiter 344', and also to assist cranial limiter 344 'in limiting penetration of cranial hook 342'. In the embodiment shown in figure 16B, both the cranial hook 342 'and the cranial limiter 344' have a tapered portion that extends from the base fork, but this tapered portion is optional. The cranial hook 342 'prevents the cranial movement of the filter towards the heart after unfolding and is configured in a modality with the design and characteristics of the hook 40, as illustrated in figure 6 and described in this document. The cranial hook 342 'may have a reduced thickness in relation to the anchor element 330', which is formed through a local modification before or after the filter formed to achieve the desired stiffness. For example, when made from a tube, the flexibility of the cranial hook 342 'can be improved by locally removing material from the inner or outer surface of the tube at the position of the 342' hook. As discussed above, with respect to hook 40, cranial hook 342 'can be configured to fold in the direction of a substantially straight configuration when a specific hook migration force is applied, and resiliently back to an original shape when the hook migration force is removed.
Figure 16C shows the cranial extension 340 'unfolded in a body vessel with the cranial hook 342' penetrating a wall of the vessel 3 and the cranial limiter 344 'coming into contact with the vessel wall 3 in order to avoid excessive penetration cranial hook 342 '. The configuration of the cranial extension 340 '(for example, through the width of the base, the length of the limiter, the flexibility of the hook, etc.) limits the penetration distance of the cranial hook 342', while preventing cranial movement. The cranial limiter 344 'is formed with a non-penetrating distal end in order to avoid penetration of the vessel wall 3. However, in some embodiments, the cranial limiter 344' can act as and / or be configured for the prevention of movement flow rate. In the illustrated embodiment, the cranial limiter 344 'is essentially straight in relation to the anchor element 330', however, in other embodiments, the cranial limiter can also be curved or angular. The skull limiter may also include an enlarged distal end in the form of a flap as shown and discussed in connection with the flow limiter below.
Figure 17A shows an enlarged view of the flow extension 350 of figure 15. In an exemplary embodiment suitable for a human adult vena cava filter, when the filter is at the person's temperature and not forced, the radius of curvature R4 is about 0.76 cm (0.03 inch), length h5 is about 0.13 cm (0.05 inch), length hβ is about 0.13 cm (0.05 inch), the h7 length is about 0.25 centimeter (0.1 inch). It should be noted that the values presented in this document are approximate, representing a dimension within a range of dimensions suitable for the specific modality illustrated in the figures, and that any suitable values can be used, as long as the values allow the filter to work as intended in a person's blood vessel.
A representation of an exemplary flow rate is illustrated in figures 17B and 17C. The flow extension 350 'forks from a base 356' into a flow anchor 352 'and a flow limiter 354'. The base 356 'has a width that is greater than that of the anchor element 330' from which it extends in the embodiment shown in order to provide a greater width for both the flow anchor 352 'and the flow limiter 354 ', and also in order to assist the flow limiter 354' in limiting the penetration of the flow anchor 352 '. In the embodiment shown in figure 17B, both the flow anchor 352 'and the limiter 354' extend from the base fork with a constant width. However, in other embodiments, both may include a conical portion similar to that of the cranial extension 340 '. The caudal anchor 352 'prevents the caudal movement of the filter out of the heart after unfolding and is configured with a distal blade configured to penetrate the vessel. The flow anchor 352 'may have a reduced thickness in relation to the anchor element 330', which is formed through a local modification before or after the formed filter reaches the desired stiffness. For example, when made from a tube, the flexibility of the flow anchor 352 'can be improved by removing material from the inner surface of the tube at the position of anchor 352' in place.
Figure 17C shows the flow extension 350 'unfolded in a vessel of the body with the flow anchor 352' penetrating a wall of the vessel 3 and the limiting flow 354 'coming into contact with the vessel wall 3 in order to avoid excessive penetration caudal anchor 352 '. The configuration of the flow extension 350 '(for example, through the width of the base, the length of the limiter, etc.) limits the penetration distance of the flow anchor 352', at the same time preventing the flow movement. The flow limiter 354 'is formed with a non-penetrating distal end in order to avoid the penetration of the vessel wall 3. In the illustrated embodiment, the flow limiter 354' is curved with respect to the anchoring element 330 ', however, in other modalities, the flow limiter can be straight or angular. The flow limiter can be longer than the flow anchor, as shown in figure 17B. Alternatively, the flow limiter can be the same length or less than the flow anchor. The flow limiter may also include an enlarged distal end in the form of a flap 358, as best seen in Figure 18.
In one embodiment, in addition to, or instead of, cranial extensions and caudal extensions, the anchoring elements include an extension with a base that forks into a cranial hook and a caudal anchor.
Again, with reference to figure 15, the filter 300 includes six locator elements 320 and six anchor elements 330 that extend from the center 310 and are arranged along a longitudinal geometric axis of the filter 300. The locator elements 320 they are alternately interposed between the anchoring elements 330 in such a way that each locating element 320 extends from the hub between adjacent pairs of anchoring elements, and vice versa. However, in other embodiments, the locating elements 320 and / or the anchoring elements 330 can be directly adjacent to each other without an interference anchor element 330 and / or locating element 320. Each of the locating elements 320 is essentially the same size and configuration, and includes four segments LS1, LS2, LS3, and LS4, as described in more detail below in relation to figure 19. Although the locating elements in the illustrated embodiment do not include hooks or anchors, in other embodiments, one or more locating elements may include an extension, a hook and / or an anchor, as described in this document. The total of anchoring elements and locating elements in other modalities can be more or less 12, as shown in the illustrated modality.
In figure 15, the six anchor elements 330 have three different lengths measured from the hub 310 along the longitudinal axis of the filter, a first length / distance from the hub 310 being the shortest (ie L10A in the figure 19), a second length / distance from cube 310 being greater than the first length / distance (that is, LIOB in figure 19), and the third length / distance from cube 310 is greater than both the first and second lengths I distances (that is, L | Oc in figure 19). In other embodiments, the anchoring elements can be two different sizes or four or more different lengths. In modalities in which anchor elements include cranial extensions, caudal extensions, cronic hooks, caudal anchors, or other forms of hooks or anchors, the provision of different lengths of anchor elements in a staggered pattern facilitates the deformation of a filter for a non-forced configuration and filter release, but it also potentially reduces the necessary components of a release system (for example, because the hooks and anchors are staggered and positioned in a compact way, as shown below in relation to the method folding, making it possible to release the filter without using a folding means or covering the hooks in the release sheath). The anchoring elements 330 have an essentially straight configuration distal to the proximal anchor end 330P, which curves outwardly from the longitudinal geometric axis of the filter in the expanded filter configuration. In other configurations, the anchor elements 330 may have one or more segments extending along different axes, similar to the anchor elements 30 shown above with reference to figures 5A and 5B.
Of the six anchor elements 330, two anchor elements extend a first distance from hub 310, two anchor elements extend a second distance from hub 310, and two anchor elements extend a third distance from the third cube 310. The pair of the first length anchor elements and the pair of second length anchor elements each include cranial extensions at a distal end thereof. The difference between the first length and the second length in a modality is measured from the tips of the cranial hooks 342 in an expanded filter configuration (not forced), that is, l_14, as shown in figure 18. In the modality shown in figure 18, l_i4 is approximately 0.13 centimeters (0.05 inches). The pair of third length anchor elements each includes flow extensions at a distal end thereof. The combination of anchoring elements with cranial extensions and caudal extensions prevents both caudal and cranial movement of the blood filter, thus stabilizing the filter in the unfolded position within a vessel of the body.
In the embodiment illustrated in figure 15, the pairs of first, second and third long anchoring elements are positioned opposite each other on the cube (that is, 180 degrees). From a top view of the filter in an expanded configuration (for example, see figure 3), using an analog clock, the pair of anchor elements is positioned as follows: when the first length anchor elements are positioned at 12 and 6, the pair of second length anchor elements are positioned at 4 and 10, and the pair of third length anchor elements are positioned at 2 and 8. As described in detail below, this respective positioning particular of the anchoring elements facilitates the preparation of the filter for loading and releasing. Other possibilities regarding the positioning of the anchor element with respect to the cube may, alternatively, be desired and, therefore, it must be appreciated that the illustrated modality is not intended to be a limiting factor.
As shown in figure 19, the locator element 320 is similar in many respects to the locator element 20, including the plurality of locator segments LS1 to LS4. However, the locator element 320 has the following dimensional parameters which may differ slightly from the locator element 20 described above. In an exemplary modality suitable for the vena cava filter of a human adult, when the filter is at the patient's temperature and not forced, the radius of curvature Ra is about 0.89 centimeter (0.35 inch), the Li length is about 1.14 cm (0.45 inch); the L2 length is about 2.54 centimeters (1.0 inch), the di distance is about 2.29 centimeters (0.9 inch), the d2 distance is about 3.23 centimeters (1.27 inches), 0 first Oi angle is about 57 degrees, the second angle θ2 is about 17 degrees, and the thickness ti of the locator element 320 along the LS2 section is about 0.03 centimeter (0.0125 inch), and along the the same LS3 section is also about 0.03 cm (0.0125 inch). The LWA longitudinal distance is about 3.68 centimeters (1.45 inches), L10B θ about 3.81 centimeters (1.50 inches), Lioc is about 4.32 centimeters (1.70 inches), and l_13 is about 5.08 centimeters (2.0 inches); d7 is about 4.06 centimeters (1.6 inches), the radius of curvature R2 is about 0.08 centimeters (0.03 inches); and the thickness t2 of the anchor is about 0.03 centimeter (0.0121 inch). It should be noted that the values presented in this document are approximate, representing a dimension within a range of dimensions suitable for the particular modality illustrated in the figures, and that any suitable values can be used, as long as the values allow the filter to work as intended in a person's blood vessel.
It should also be noted that, although the thickness of the locator element 320 and the anchor element 330 is described in an exemplary embodiment as being uniform throughout its length (for example, having the same thickness as the rest of the filter 300), other embodiments include varying thicknesses along the length of the locating element. For example, the locator element and / or anchor element can include segments with different thicknesses or have varying thicknesses along selected segments. It should also be noted that the widths of the locating element and / or the anchoring elements may vary similarly along their lengths. For example, in one embodiment, the width of the LSi locator segment is greater than that of the other locator segments that have a uniform width. In addition, although the anchoring elements 330 of the filter 300 are wider than the locating elements 320, in other embodiments, the anchoring elements and locating elements may be of the same width, or the locating elements may be wider than the anchoring elements.
As described in this document, filter 300 is cut from a metal tube (for example, Nitinol). The formation of the filter 300 from a tube provides the opportunity to locally reduce the thickness of the filter sections, such as, for example, the cranial hook 342 and / or the caudal anchor 352. After laser cutting the tube and filter formation, electropolishing, chemical attack or other similar processes can be used to improve the surface finish for greater resistance to corrosion and fatigue life. It should also be noted that the filter 300 can be formed from threads or foil.
The filter hub 310 can include a recovery element 312, as shown in figure 15. The recovery element 312 can be formed from a solid rod with an extension 313 that can be inserted into the open end of the hub 310, as shown in figure 20, and then welded, crimped or otherwise permanently connected to hub 310. Alternatively, the recovery element 312 can be formed directly from the tube from which the filter is formed, as shown in the figures 21A and 21B. Figure 21A is a side view of the recovery element 312 and figure 21B is a front view of the recovery element 312. As can be seen from figure 21, any number of patterns and formations can be cut from the tube in to improve the recoverability of the filter 300.
An exemplary method of preparing the filter 300 for loading and releasing is shown in figures 22 to 26. The positioning of the anchoring elements 330 in relation to each other and the other features of the filter facilitate the deformation of the filter 300 in a low profile, in partly due to the staggered lengths of the anchoring elements 330. The filter 300 includes six anchoring elements and six locating elements, which for reference purposes are successively numbered counterclockwise on the circumference of the hub 310 when viewed from the ends distal elements of the anchor as the first, second, third, fourth, fifth and sixth anchor elements, and as the first, second, third, fourth, fifth and sixth locating elements, the first locating element being positioned closest to the clockwise direction of the first anchor element (that is, extending between the first anchor element and the sixth anchor element act). It should be appreciated that the method shown and described is just an example and many variations are possible. For example, although the third LS3 segment of the locator element is described as being positioned behind the anchor element, any length of a locator element or its equivalent component in a blood filter can be positioned. In addition, the positioning order can vary, as well as the positioning of the locating elements in relation to each other. Furthermore, instead of placing a length of locating elements behind two anchoring elements, the length of locating elements can be positioned behind one, three or more anchoring elements.
Figure 22 shows the filter 300 with the anchoring elements limited in a deformed configuration by means of a tube 4; however, other methods and / or limiting devices are also possible. Tube 4 slides over hub 310 towards the distal ends of anchor 330D until the distal end of the tube juxtaposes to the cranial hooks on the first length anchor. The locator elements 320 are removed from the tube (when the tube initially covers the ends of the tube) so that they are in an expanded configuration, as shown in figure 22. As shown in figure 23, the third locator segment LS3 of the first element locator 320i is positioned behind (that is, in the direction of the longitudinal geometric axis of the filter) the first anchor element 330i and the second anchor element 3302 such that a distal end of the first locator element 320i extends between the second element of anchor 3302 and the third anchor element 3303. As shown in figure 24, the third locator segment LS3 of the second locator element 3202 is then positioned behind the second anchor element 3302 and the third anchor element 3303 in such a way that a distal end of the second locating element 32Ü2 extends between the third anchoring element 3303 and the fourth anchor element 3304.
The third locator segment l_S3 of the third locator element 32O3 is then positioned behind the third anchor element 3303 and the fourth anchor element 3304 such that a distal end of the third locator element 3203 extends between the fourth anchor element 3304 and the fifth anchor 3305. The third locator segment LS3 of the fourth locator element 3204 is then positioned behind the fourth anchor element 3304 and the fifth anchor element 3305 such that a distal end of the fourth locator element 3204 extends between the fifth anchor 3305 and the sixth anchor 330e. The third locator segment l_S3 of the fifth locator element 3205 is then positioned behind the fifth anchor element 3305 and the sixth anchor element 330β such that a distal end of the fifth locator element 3205 extends between the sixth anchor element 3306 and the first anchor element 330 ^ Finally, the third locator segment LS3 of the sixth locator element 3206 is positioned behind the sixth anchor element 330Θ and the first anchor element 330i such that a distal end of the sixth locator element 3206 extends between the first anchor element 330i and the second anchor element 3302.
In this particular modality, in addition to being positioned behind two anchoring elements, the locating elements are positioned in such a way that, when viewed from the distal end of the 330D anchoring elements, each locating element is under (that is, cross below) its previous locator element in number (for example, the second locator element is positioned under the first locator element). This positioning configuration is shown in figure 25, whose figure is simplified in order to show schematically the relative positioning of the locating element (for example, only a representative length of the locating element positioned behind the anchoring elements is shown). In other embodiments, some of the locating elements can preferably be positioned over the adjacent locating elements.
Once the locator elements 320 are threaded in position, the filter is partially pulled into a release sheath or stagger sheath 5, as shown in figure 26. The positioning of the anchor element extensions is checked to ensure that the anchor elements with caudal extensions are surrounded by anchor elements with cranial extensions. In one embodiment, the flow extensions are positioned in such a way that the flow limiters are adjacent to each other so that the flat surfaces are together in order to avoid capturing the flow anchors after the filter unfolds. The positioning of the anchor element is then revised to ensure that the cranial hooks are all turned in one direction (for example, clockwise). In order to position the cranial hooks, for example, when the cranial hooks face outward from the longitudinal geometric axis or meet in different directions, the filter is twisted as it is pulled into the release sheath. The cranial hooks follow the path of least resistance and remain twisted until they are circumferentially oriented. In one embodiment, the cranial extensions are oriented in such a way that the cranial hooks sit against the inner wall of the sheath and the cranial restraints sit outside the inner wall of the sheath for beneficial distribution of the available volume. Once properly oriented, the filter is completely pulled into the release sheath.
In one embodiment, the method of preparing the filter for release is generally described in relation to the total number N of anchoring elements and the same number N of locating elements that extend from the filter hub, the locating elements being interposed between the anchoring elements. As in the example above, both the anchoring elements and the locating elements are arranged and listed successively counterclockwise on a circumference of the cube when viewed from a distal end of the filter, such that a particular locating element does not remain positioned immediately adjacent clockwise for a given anchor element n. Furthermore, according to the example above, the anchoring elements include both a cranial extension and a caudal extension at a distal end thereof. Assuming that a number N is greater than 5, after limiting the anchoring elements, the method includes (i) limiting the anchoring elements to a deformed configuration; (ii) positioning a length of the locator element 1 behind the anchor element 1 and the anchor element 2 such that a distal end of the locator element 1 extends between the anchor element 2 and the anchor element 3, (iii) the repetition of step (ii) for the locating elements 2, 3 ,. . . and N-2; (iv) positioning a length of locator element N-1 behind anchor element N-1 and anchor element N such that a distal end of locator element N-1 extends between anchor element N and the anchor element 1; (v) positioning a length of locator element N behind anchor element N and anchor element 1 such that a distal end of locator element N extends between an anchor element and anchor element 2; (vi) checking if the anchoring elements with tail extensions are involved by the anchoring elements with cranial extensions; and (vii) dragging the filter to a release sheath.
The present invention has been described and specific examples of the present invention have been portrayed. Although the present invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the present invention is not limited to the variations or figures described. In addition, when the methods and steps described above indicate certain events that occur in a certain order, those with simple skill in the art will recognize that the ordering of certain steps can be modified and that such changes are in accordance with the variations of the present invention . In addition, some of the steps can be performed simultaneously in a parallel process when possible, as well as performed sequentially, as described above. Therefore, insofar as there are variations of the present invention that are within the spirit of its material or equivalent to the inventions found in the claims, it is intended that the present patent, likewise, covers these variations. Finally, all publications and patent applications cited in this specification are incorporated into this document as a reference in their entirety, as if each individual publication or patent application was specifically and individually addressed in this document. .

权利要求:
Claims (29)
[0001]
1. Filter (300) to be placed in a blood flow through a vessel, comprising: - a cube (310) arranged along a longitudinal geometric axis; - a plurality of anchoring elements (330) extending from the hub (310), each anchoring element including a cranial extension (340) or a caudal extension (350) at a distal end (330D) thereof, at least at least one distal end of the anchor element being spaced from the hub (310) in each of a first, second, and third distance along the longitudinal geometric axis, and - a plurality of locating elements (320), each locating element extending from the hub (310) between an adjacent pair of anchoring elements (330), characterized by the fact that the flow extensions (350) include a flow anchor (352) and a flow limiter (354) that extend separately to from a flow base (356) with a width greater than the width of the anchor element (330).
[0002]
2. Filter according to claim 1, characterized by the fact that the plurality of anchoring elements (330) consists of six anchoring elements (330), and the plurality of locating elements (320) consists of six elements locators (320), the six locator elements (320) being of the same length, each locator element including four segments (LS1, LS2, LS3, LS4), each of the segments being arranged in respective distinct axes (A, 110, 120, 130), and four of the six anchor elements (330) include a cranial extension (340), and the remaining two anchor elements among the six anchor elements (330) include a tail extension (350).
[0003]
3. Filter according to claim 2, characterized by the fact that at least one anchor element (330) with a cranial extension (340) has a distal end (330D) spaced from the hub (310) in the first distance, and at least one anchor element (330) with a cranial extension (340) has a distal end (330D) spaced from the hub (310) in the second distance.
[0004]
4. Filter according to claim 3, characterized by the fact that two anchoring elements (330) with cranial extensions (340) have a distal end (330D) spaced from the hub (310) in the first distance, two anchoring elements (330) with cranial extensions (340) have a distal end (330D) spaced from the hub (310) in the second distance, and two anchor elements (330) with caudal extensions (350) have a distal end (330D) spaced from the hub (310) in the third distance.
[0005]
5. Filter according to claim 4, characterized by the fact that the two anchoring elements (330) with flow extensions (350) extend from the opposite sides of the hub (310).
[0006]
6. Filter according to claim 5, characterized by the fact that the two anchoring elements (330) with cranial extensions (340) having a distal end (330D) spaced from the hub (310) in the first distance extend from opposite sides of the hub (310), and in which the two anchoring elements (330) with cranial extensions (340) having a distal end (330D) spaced from the hub (310) in the second distance extend from the sides opposite sides of the cube (310).
[0007]
7. Filter according to claim 1, characterized by the fact that the cranial extensions (340) include a cranial hook (342) and a cranial limiter (344) that extend separately from a cranial base (346) having a width greater than the width of the anchor element (330), the cranial hook (342) comprising a curved configuration in an operational condition and a generally linear configuration in a restricted condition.
[0008]
8. Filter according to claim 1, characterized in that the flow limiter (354) includes a flap element (358) at a distal end thereof.
[0009]
9. Filter, according to claim 1, characterized by the fact that the filter (300) is formed from a Nitinol tube, including a recovery element produced separately from a metal rod and connected to the hub ( 310).
[0010]
10. Method of preparing the filter (100, 200, 300) as defined in claim 1, for releasing into a vessel from the body, the six anchoring elements (330) comprising a first, second, third, fourth, fifth and sixth elements anchoring elements arranged successively counterclockwise over a circumference of the hub (310) when viewed from the distal ends of the anchoring element (330D), the six locating elements (320) comprising a first, second, third, fourth, fifth and six locating elements (320) arranged successively counterclockwise over a circumference of the hub (310) when viewed from the distal ends of the anchoring element (330D), the method characterized by the fact that it comprises the steps of: (i ) limiting the anchoring elements (30, 330, 330 ', 330D) to a deformed configuration; (ii) positioning a length of the first locating element nearest clockwise of the first anchoring element (3301) behind the first anchoring element (3301) and the second anchoring element (3302) such that a distal end of the first locator element (3201) extends between the second anchor element (3302) and the third anchor element (3303); (iii) positioning a length of the second locator element (3202) behind the second anchor element (3302) and the third anchor element (3303) such that a distal end of the second locator element (3202) extends between the third anchor element (3303) and the fourth anchor element (3304); (iv) positioning a length of the third locator element (3203) behind the third anchor element (3303) and the fourth anchor element (3304) such that a distal end of the third locator element (3203) extends between the fourth anchor element (3304) and the fifth anchor element (3305); (v) positioning a length of the fourth locator element (3204) behind the fourth anchor element (3304) and the fifth anchor element (3305) such that a distal end of the fourth locator element (3204) extends between the fifth anchor element (3305) and the sixth anchor element (3306); (vi) positioning a length of the fifth locator element (3205) behind the fifth anchor element (3305) and the sixth anchor element (3306) such that a distal end of the fifth locator element (3205) extends between the sixth anchor element (3306) and the first anchor element (3301); (vii) positioning a length of the sixth locator element (3206) behind the sixth anchor element (3306) and the first anchor element (3301) such that a distal end of the sixth locator element (3206) extends between the first anchor element (3301) and the second anchor element (3302); (viii) verify that the anchor elements (330) with tail extension (350) are surrounded by the anchor elements (330) with cranial extensions (340); and (ix) pull the filter (300) to a release sheath (5).
[0011]
11. Method according to claim 10, characterized by the fact that the cranial extensions (340) each include a cranial hook (342), further comprising the step of verifying whether the cranial hooks are in the same direction, and further twisting the filter (300) during the pulling step (ix).
[0012]
12. Method according to claim 10, characterized in that the step of limiting (i) comprises the sliding of a tube (4) over the hub (310) towards the distal end of the anchoring elements (330D) , the tube having a shorter length than the first distance.
[0013]
13. Method according to claim 10, characterized by the fact that each of the locating elements (320) includes four segments (LS1, LS2, LS3, LS4) arranged on respective distinct axes (A, 110, 120, 130) consecutively numbered from a proximal end (320P) of the locator element to a distal end (320D) of the locator element, the steps of positioning including the positioning of the third segments (LS3) of the locator elements (320) behind the anchor elements ( 330).
[0014]
14. Method, according to claim 10, characterized by the fact that after the positioning step (vii), each of the locating elements (320) has a portion positioned under the nearest locating element clockwise.
[0015]
15. Method of preparing the filter (300) as defined in claim 1 for release into a body vessel, characterized by the fact that the filter (300) comprises N anchoring elements (330) arranged and numbered successively in a counterclockwise direction on a hub circumference (310) when viewed from a distal filter end, and the N locating elements (320) arranged and listed successively counterclockwise on a hub circumference (310) when viewed from the end distal filter, and arranged in such a way that the locating element n is immediately positioned clockwise adjacent to the anchoring element n, where N is greater than 5, the method comprising the steps of: (i) limiting the anchoring elements (330) to a deformed configuration; (ii) position the length of the locator element (1) behind the anchor element (1) and the anchor element (2) such that a distal end of the locator element (1) extends between the anchor element (2 ) and the anchoring element (3); (iii) repeat step (ii) for the locating elements (2, 3,...) and N-2; (iv) positioning a length of the locating element N-1 behind the anchoring element and anchoring element N such that a distal end of the locating element N-1 extends between the anchoring element N and the anchoring element ( 1); (v) positioning a length of the locating element N behind the anchoring element N and the anchoring element (1) such that a distal end of the locating element N extends between the anchoring element (1) and the anchoring element (two); (vi) verify that the anchor elements (330) with the tail extensions (350) are surrounded by the anchor elements (330) with cranial extensions (340); and (vii) pulling the hub (310) into a release sheath (5).
[0016]
16. Filter (300) to be placed in a blood stream through a vessel, comprising: - a cube (310) arranged along a longitudinal geometric axis; - a plurality of anchoring elements (330, 330 ') extending from the hub, each anchoring element including a cranial extension (340, 340') or a caudal extension (350, 350 ') at one end distal (330D) of the same, at least one distal end of the anchoring element (330D) being spaced from the hub in each of the first (L10A), second (L10B), and third (L10c) distance along the longitudinal geometric axis , and - a plurality of locating elements (320), each locating element extending from the hub between an adjacent pair of anchoring elements, characterized by the fact that the cranial extensions (340, 340 ') include a cranial hook ( 342, 342 ') and a cranial limiter (344, 344') which extend separately from a cranial base (346, 346 ') with a width greater than the width of the anchor.
[0017]
17. Filter (300) according to claim 16, characterized in that the plurality of anchoring elements (330, 330 ') consists of six anchoring elements (320), and the plurality of locating elements consists of six locating elements, the six locating elements being of the same length, each locating element including four segments (LS1, LS2, LS3, LS4), each of the segments being arranged in respective distinct axes, and four of the six Anchor elements include a cranial extension (340, 340 '), and the remaining two anchor elements among the six anchor elements include a tail extension (350, 350').
[0018]
18. Filter (300) according to claim 17, characterized by the fact that at least one anchor element (330, 330 ') with a cranial extension (340, 340') has a distal end (330D) spaced from the hub (310) in the first distance (L10A), and at least one anchor element (330, 330 ') with a cranial extension (340, 340') has a distal end (330D) spaced from the hub in the second distance (L10B) .
[0019]
19. Filter according to claim 18, characterized by the fact that two anchoring elements (330, 330 ') with cranial extensions (340, 340') have a distal end (330D) spaced from the hub at the first distance (L10A) two anchor elements with cranial extensions (340, 340 ') have a distal end spaced from the hub in the second distance (L10B), and two caudal extension anchors (350') have a spaced distal end of the hub in the third distance (L10C).
[0020]
20. Filter according to claim 19, characterized in that the two anchoring elements (330, 330 ’) with flow extension (350, 350’) extend from the opposite sides of the hub (310).
[0021]
21. Filter according to claim 20, characterized by the fact that the two anchoring elements (330, 330 ') with stud extensions (340, 340') having a distal end (330D) spaced from the hub in the first distance (L10A) extends from the opposite sides of the cube, and in which the two anchoring elements with cranial extensions having a distal end spaced from the cube in the second distance (L10B) extend from the opposite sides of the cube.
[0022]
22. Filter according to claim 16, characterized in that the cranial hook (342, 342 ') comprises a curved configuration in an operational condition and a generally linear configuration in a restricted condition.
[0023]
23. Filter according to claim 16, characterized in that the flow extensions (350, 350 ') include a flow anchor (352, 352') and a flow limiter (354, 354 ') which extends separately from a flow base (356, 356 ') having a width greater than the width of the anchor element (330, 330'), and the flow limiter includes a flap element (358) at a distal end thereof.
[0024]
24. Filter, according to claim 16, characterized by the fact that the filter is formed from a Nitinol tube, including a recovery element (312) produced separately from a metal rod and connected to the hub.
[0025]
25. Method of preparing the filter as defined in claim 16, for releasing into a vessel from the body, the six anchoring elements (330, 330 ') comprising a first (3301), second (3302), third (3303), fourth (3304), fifth (3305) and sixth (3306) anchoring elements arranged successively counterclockwise over a circumference of the hub (310) when viewed from the distal ends of the anchoring element (330D) the six locating elements (320 ) comprising a first (3201), second (3202), third (3203), fourth (3204), fifth (3205) and sixth (3206) locating elements arranged successively counterclockwise over a circumference of the cube when viewed from from the distal ends of the anchoring element, the method characterized by the fact that it comprises the steps of: (i) limiting the anchoring elements to a deformed configuration; (ii) positioning a length of the first locating element nearest clockwise from the first anchoring element behind the first anchoring element and the second anchoring element such that a distal end of the first locating element extends between the second anchoring element anchoring and the third anchoring element; (iii) positioning a length of the second locating element behind the second anchoring element and the third anchoring element such that a distal end of the second locating element extends between the third anchoring element and the fourth anchoring element; (iv) positioning a length of the third locator element behind the third anchor element and the fourth anchor element such that a distal end of the third locator element extends between the fourth anchor element and the fifth anchor element; (v) positioning a length of the fourth locator element behind the fourth anchor element and the fifth anchor element such that a distal end of the fourth locator element extends between the fifth anchor element and the sixth anchor element; (vi) positioning a length of the fifth locator element behind the fifth anchor element and the sixth anchor element such that a distal end of the fifth locator element extends between the sixth anchor element and the first anchor element; (vii) positioning a length of the sixth locator element behind the sixth anchor element and the first anchor element such that a distal end of the sixth locator element extends between the first anchor element and the second anchor element; (viii) check if the caudal extension anchors (350, 350 ’) are surrounded by the cranial extension anchors (340, 340’); and (ix) pull the filter into a release sheath (5).
[0026]
26. Method, according to claim 25, characterized by the fact that the cranial extensions (340, 340 ') each include a cranial hook (342, 342'), further comprising the step of verifying whether the cranial hooks are in the same direction, and still twist the filter during the pulling step (ix).
[0027]
27. Method according to claim 25, characterized in that the step of limiting (i) comprises the sliding of a tube (4) over the hub towards the distal end of the anchoring elements, the tube having a length less than the first distance.
[0028]
28. Method according to claim 25, characterized by the fact that each of the locating elements (320) includes four segments arranged on respective distinct axes listed consecutively from a proximal end of the locating element to a distal end of the locating element , the steps of positioning including the positioning of the third segments of the locating elements behind the anchoring elements.
[0029]
29. Method, according to claim 25, characterized by the fact that after the positioning step (vii), each of the locating elements has a portion positioned under the nearest locating element in a clockwise direction.

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同族专利:

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公开号 | 公开日

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AU2010278893B2|2014-02-27|

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CN102470028B|2015-04-15|

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JP5685253B2|2015-03-18|

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BR112012001978A2|2016-03-29|

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US10813738B2|2020-10-27|

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CA2769208C|2017-10-31|

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CN102470028A|2012-05-23|

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ES2717424T3|2019-06-21|

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US20150238302A1|2015-08-27|

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US20190336263A1|2019-11-07|

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US9486304B2|2016-11-08|

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US20170027681A1|2017-02-02|

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US20210068939A1|2021-03-11|

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JP2013500787A|2013-01-10|

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EP2459119A1|2012-06-06|

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US8613754B2|2013-12-24|

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MX2012001288A|2012-06-19|

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US9017367B2|2015-04-28|

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EP3505136A1|2019-07-03|

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US20100318115A1|2010-12-16|

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US9895214B2|2018-02-20|

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EP2459119B1|2019-01-16|

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AU2010278893A1|2012-02-23|

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WO2011014703A1|2011-02-03|

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BR112012001978B8|2021-06-22|

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US20140107695A1|2014-04-17|

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CN104825247B|2017-05-03|

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CA2769208A1|2011-02-03|

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法律状态:
2019-01-15| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-07-02| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|

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2019-11-19| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2020-04-07| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2020-07-28| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-01| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 01/12/2020, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/07/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |

优先权:

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申请号 | 申请日 | 专利标题

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US22958009P| true| 2009-07-29|2009-07-29|

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US61/229,580|2009-07-29|

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PCT/US2010/043787|WO2011014703A1|2009-07-29|2010-07-29|Tubular filter|

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