Migration resistant embolic filter
11617640 · 2023-04-04
Assignee
Inventors
Cpc classification
A61F2/0105
HUMAN NECESSITIES
International classification
Abstract
An embolic filter is disclosed and can include a head. A plurality of bent legs can extend from the head. Each bent leg can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. A plurality of straight legs can also extend from the head. Each straight leg can be configured to prevent the embolic filter from migrating in a caudal direction.
Claims
1. An embolic filter having a filter central longitudinal axis and configured for placement in a patient's vessel having a vessel wall, comprising: a) a head having a proximal end, a distal end and a head length; b) a first plurality of appendages that extend distally from the head distal end, each having a distal anchor spaced distally away from the head a distance greater than the head length; c) a second plurality of appendages each appendage of the second plurality having a central longitudinal axis; d) a third plurality of appendages that are each shorter than any appendage of the first or second plurality of appendages; e) the distal anchors of the first plurality of appendages defining curved anchor ends that are spaced distally away from the head, the distal anchors configured to engage the vessel wall of a vein distally of the head to prevent movement of the filter in a first direction within a blood vessel; f) the appendages of the second plurality having ends that are spaced distally away from the head that define second anchors, the second anchors configured to prevent movement of the filter in a second direction that is opposite the first direction; g) each of the second anchors having a distal most tip, each of the second anchors including a vessel engaging surface that faces away from the filter central longitudinal axis and that faces toward the vessel wall, the vessel engaging surface forming an obtuse angle with the appendage central longitudinal axis; h) wherein the appendage central longitudinal axis intersects the vessel engaging surface; i) wherein the anchors of the first plurality of appendages are of a configuration that differs from the configuration of the anchors of the second plurality of appendages; j) the filter having a pre-deployment position that aligns all of the appendages together distally of the head and next to the central longitudinal axis; k) the filter having a deployed position wherein all of the appendages are spaced radially away from the filter central longitudinal axis; l) wherein the spacing between an anchor of the first plurality of appendages and an anchor of the second plurality of appendages in both pre-deployed and deployed positions is smaller than the spacing between the head and an anchor of the first plurality of appendages or an anchor of the second plurality of the appendages; and m) wherein in the pre-deployed position, all of the anchors are closer to the filter central longitudinal axis than to said head.
2. The embolic filter of claim 1, wherein each appendage of the first plurality includes a center and wherein the proximal ends of the appendages of the first plurality are arranged within the head so that the centers of the appendages of said first plurality form an equilateral triangle within the head.
3. The embolic filter of claim 2, wherein the proximal ends of the appendages of the second plurality are each disposed within the head in contact with the proximal ends of the appendages of the first plurality.
4. Apparatus including the embolic filter of claim 1 and a filter delivery system that includes a catheter and wherein when the embolic filter is in a collapsed position within the catheter, the appendages extend in one direction from the head.
5. The embolic filter of claim 1 wherein the head has a central longitudinal axis, each appendage of said first plurality is a bent appendage having a distal end and a bend in between the head and the distal end that divides each bent appendage into proximal and distal sections, the proximal section of each bent appendage forming a first acute angle with the head axis, the distal section of each bent appendage forming a second acute angle with the head axis that is larger than the first angle.
6. The embolic filter of claim 1, wherein the vein vessel wall engaging surface is generally aligned with the central longitudinal axis of the head.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
DETAILED DESCRIPTION OF THE DRAWINGS
(11) An embolic filter is disclosed and can include a head. A plurality of bent legs can extend from the head. Each bent leg can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. A plurality of straight legs can also extend from the head. Each straight leg can be configured to prevent the embolic filter from migrating in a caudal direction.
(12) In another embodiment, an embolic filter is disclosed and can include a head. A first plurality of legs can extend from the head. Each of the first plurality of legs can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. Also, each of the first plurality of legs can include a first leg diameter. The embolic filter can also include a second plurality of legs that can extend from the head. Each of the second plurality of legs can be configured to prevent the embolic filter from migrating in a caudal direction and each of the second plurality of legs can have a second leg diameter that is at least 1.2 times greater than the first leg diameter.
(13) In yet another embodiment, an embolic filter is disclosed and can include a head. A first bent arm, a second bent arm, a third bent arm, a fourth bent arm, a fifth bent arm, and a sixth bent arm can extend from the head. Each bent arm can include a proximal end and a bent arm diameter. Moreover, a first bent leg, a second bent leg, and a third bent leg can extend from the head. Each bent leg can include a proximal end and a bent leg diameter that is substantially equal to the bent arm diameter. In this embodiment, a first straight leg, a second straight leg, and a third straight leg can extend from the head. Each straight leg has a proximal end and a straight leg diameter that is at least 1.2 times greater than the bent leg diameter or the bent arm diameter.
(14) Description of the Relevant Anatomy
(15) Referring to
(16) Description of a Filter Delivery Device
(17)
(18) As depicted in
(19) In a particular embodiment, an embolic filter 224 can be stored within the filter storage tube 216. As shown, the embolic filter 224 can be formed into a collapsed configuration and installed within the filter storage tube 216. The embolic filter 218 can be the embolic filter described below. Further, the embolic filter 218 can be made from a shape memory material. The shape memory material can be a shape memory polymer. Further, the shape memory material can be a shape memory metal. The shape memory metal can be a nickel titanium alloy such as nitinol.
(20)
(21) During installation of the embolic filter, the installation catheter 222 can be threaded into the cardiovascular system of a patient, e.g., the cardiovascular system 100 described above, in order to deliver and deploy the embolic filter to the desired location with the patient. For example, the installation catheter 222 can be threaded through the femoral artery into the inferior vena cava of the patient. A distal end of the installation catheter 222 can include a pair of radiopaque bands spaced a predetermined distance apart. Using fluoroscopy, the radiopaque bands can indicate when the distal end of the installation catheter 222 is located at or near the desired location within the inferior vena cava.
(22) When the distal end of the installation catheter 222 is in the desired location within the inferior vena cava, the pusher wire 226 can be moved through the body 202 of the filter delivery device 200, through the filter storage tube 216 and into the installation catheter 222. As the pusher wire 226 is pushed through the filter storage tube 216, the embolic filter 224 is pushed from within the filter storage tube 216 into the installation catheter 222. The embolic filter 224 can be pushed through the installation catheter 222 until it is expelled from the distal end of the installation catheter 222 into the inferior vena cava. Upon exiting the installation catheter 222, the embolic filter 224 can be warmed by the body temperature of the patient. When the embolic filter 224 reaches approximately thirty-seven degrees Celsius (37° C.), e.g., normal body temperature, the embolic filter 224 can move from the collapsed configuration to an expanded configuration within the inferior vena cava. Thereafter, the installation catheter 222 can be withdrawn from the patient.
(23) Description of an Embolic Filter
(24) Referring now to
(25) As indicated in
(26) The primary bent arm angle 326 can be approximately forty-five degrees (45°). In another embodiment, the primary bent arm angle 326 can be approximately fifty degrees (50°). In yet another embodiment, the primary bent arm angle 326 can be approximately fifty-five degrees (55°). In still another embodiment, the primary bent arm angle 326 can be approximately sixty degrees (60°). In another embodiment, the primary bent arm angle 326 can be approximately sixty-five degrees (65°).
(27) The second portion 322 can be angled with respect to the first portion 320 to form a secondary bent arm angle 328. In particular, the second portion 322 can be angled inward with respect to the first portion 320, e.g., toward the longitudinal axis 324 of the embolic filter 300.
(28) In a particular embodiment, the secondary bent arm angle 328 can be approximately twenty degrees (20°). In another embodiment, the secondary bent arm angle 328 can be approximately twenty-five degrees (25°). In yet another embodiment, the secondary bent arm angle 328 can be approximately thirty degrees (30°). In still another embodiment, the secondary bent arm angle 328 can be approximately thirty-five degrees (35°). In another embodiment, the secondary bent arm angle 328 can be approximately forty degrees (40°). In yet still another embodiment, the secondary bent arm angle 328 can be approximately forty-five degrees (45°).
(29) In a particular embodiment, each bent arm 308, 310, 312, 314, 316, 318 is movable between a straight configuration, shown in
(30) As further illustrated in
(31) In a particular embodiment, the primary bent leg angle 340 can be approximately twenty degrees (20°). In another embodiment, the primary bent leg angle 340 can be approximately twenty-five degrees (25°). In yet another embodiment, the primary bent leg angle 340 can be approximately thirty degrees (30°). In still another embodiment, the primary bent leg angle 340 can be approximately thirty-five degrees (35°). In another embodiment, the primary bent leg angle 340 can be approximately forty degrees (40°). In yet still another embodiment, the primary bent leg angle 340 can be approximately forty-five degrees (45°).
(32) The second portion 338 of each bent leg 330, 332, 334 can extend be angled with respect to the first portion 336 in order to form a secondary bent leg angle 342. Specifically, the second portion 338 can be angled outward relative to the first portion 336, e.g., away from the longitudinal axis 324 of the embolic filter 300.
(33) In a particular embodiment, the secondary bent leg angle 342 is approximately five degrees (5°). In another embodiment, the secondary bent leg angle 342 is approximately ten degrees (10°). In still another embodiment, the secondary bent leg angle 342 is approximately fifteen degrees (15°). In yet another embodiment, the secondary bent leg angle 342 is approximately twenty degrees (20°). In another embodiment, the secondary bent leg angle 342 is approximately twenty-five degrees (25°).
(34) In a particular embodiment, each bent leg 330, 332, 334 is movable between a straight configuration, shown in
(35) Each bent leg 330, 332, 334 can also include a foot 344. As shown in
(36)
(37) In a particular embodiment, the primary straight leg angle 356 can be approximately twenty degrees (20°). In another embodiment, the primary straight leg angle 356 can be approximately twenty-five degrees (25°). In yet another embodiment, the primary straight leg angle 356 can be approximately thirty degrees (30°). In still another embodiment, the primary straight leg angle 356 can be approximately thirty-five degrees (35°). In another embodiment, the primary straight leg angle 356 can be approximately forty degrees (40°). In yet still another embodiment, the primary straight leg angle 356 can be approximately forty-five degrees (45°).
(38) Each straight leg 350, 352, 354 can include a distal end 358 that is configured to engage the inner wall of the vein in which the embolic filter 300 is installed. In particular, as shown in
(39) In a particular embodiment, the vein engagement face angle 364 can be ninety degrees (90°). In another embodiment, the vein engagement face angle 364 can be ninety-five degrees (95°). In still another embodiment, the vein engagement face angle 364 can be one hundred degrees (100°). In another embodiment, the vein engagement face angle 364 can be one hundred five degrees (105°). In yet another embodiment, the vein engagement face angle 364 can be one hundred ten degrees (110°). In another embodiment, the vein engagement face angle 364 can be one hundred fifteen degrees (115°).
(40) In still yet another embodiment, the vein engagement face angle 364 can be one hundred twenty degrees (120°). In another embodiment, the vein engagement face angle 364 can be one hundred twenty five degrees (125°). In yet another embodiment, the vein engagement face angle 364 can be one hundred thirty degrees (130°). In another embodiment, the vein engagement face angle 364 can be one hundred thirty five degrees (135°). In another embodiment, the vein engagement face angle 364 can be one hundred forty degrees (140°). In another embodiment, the vein engagement face angle 364 can be one hundred forty five degrees (145°). In another embodiment, the vein engagement face angle 364 can be one hundred fifty degrees (150°).
(41) As depicted in
(42) Enlarging the distal end 358 of each straight leg 350, 352, 354 can allow the vein engagement face 360 to be enlarged which can increase the engagement of the vein engagement face 360 with the vein in which the embolic filter 300 is installed. However, the distal end 358 of each straight leg 350, 352, 354 can have the same diameter as the straight leg 350, 352, 354.
(43) In a particular embodiment, the vein engagement face 360 can be roughened. For example, the roughening process can include acid etching; application of a bead coating, e.g., cobalt chrome beads; application of a roughening spray, e.g., titanium plasma spray (TPS); laser blasting; or any other similar process or method. Roughening the vein engagement face 360 can increase the engagement of the vein engagement face 360 with the inner wall of the vein in which the embolic filter is installed. The vein engagement face 360 of each straight leg 350, 352, 354 can substantially prevent caudal migration of the embolic filter 300. In other words, the vein engagement face 360 can engage the inner wall of the vein and substantially prevent the embolic filter 300 from moving downstream in a caudal direction within the vein.
(44) Each bent arm 308, 310, 312, 314, 316, 318 can include a bent arm length. Further, each bent leg 330, 332, 334 can include a bent leg length. Moreover, each straight leg 350, 352, 354 can include a straight leg length. In a particular embodiment, the bent arm length is approximately six-tenths times (0.6 x) the bent leg length. In another embodiment, the bent arm length is approximately six and one-half tenths times (0.65 x) the bent leg length. In yet another embodiment, the bent arm length is approximately seven-tenths times (0.7 x) the bent leg length. In still another embodiment, the bent arm length is approximately seven and one-half tenths times (0.75 x) the bent leg length. In another embodiment, the bent arm length is approximately eight tenths times (0.8 x) the bent leg length.
(45) In a particular embodiment, the straight leg length is approximately ninety-five one hundreds times (0.95 x) the bent leg length. In another embodiment, the straight leg length is approximately ninety-six one hundreds times (0.96 x) the bent leg length. In yet another embodiment, the straight leg length is approximately ninety-seven one hundreds times (0.97 x) the bent leg length. In still another embodiment, the straight leg length is approximately ninety-eight one hundreds times (0.98 x) the bent leg length. In another embodiment, the straight leg length is approximately ninety-nine one hundreds times (0.99 x) the bent leg length. In yet another embodiment, the straight leg length is approximately equal to the bent leg length.
(46) During installation and deployment, the vein engagement face 360 of each straight leg 350, 352, 354 can allow the embolic filter 300 to move in a cranial direction. As such, the embolic filter 300 can be moved in the cranial direction to allow the bent legs 330, 332, 334, e.g., the feet 344 thereof, to engage the inner wall of the vein. The straight legs 350, 352, 354, however, can prevent the embolic filter 300 from moving caudally and allowing the feet 344 of the bent legs 330, 332, 334 to disengage from the inner wall of the vein. As such, the embolic filter 300 can be substantially locked and place within the vein and the embolic filter 300 can be prevented from moving cranially or caudally within the vein. In a particular embodiment, cranial migration is toward a patient's head and caudal migration is longitudinally opposite the cranial migration, i.e., toward a patient's lower end.
(47) Referring now to
(48) A ratio of the bent arm diameter 902 to the straight leg diameter 906 is in a range of 0.33 to 0.83. Also, a ratio of the bent leg diameter 904 to the straight leg diameter 906 is in a range of 0.33 to 0.83. Stated differently, the straight leg diameter 906 is at least one and two-tenths times (1.2 x) greater than the bent leg diameter 904, or the bent arm diameter 902. Further, in the straight leg diameter 906 is not greater than three times (3 x) greater than the bent leg diameter 904, or the bent arm diameter 902. The relatively larger diameter can provide additional stiffness that is desirable to prevent caudal migration. For example, the increased stiffness of the straight legs 350, 352, 354 can cause the straight legs 350, 352, 354 to splay radially outward and provide an outward force to maintain the vein engagement face 360 of each straight leg 350, 352, 354 in contact with the inner wall of the vein in which the embolic filter 300 is installed. Accordingly, the stiffer legs can decrease the likelihood of caudal migration of the embolic filter 300.
(49) The cross-section view shows a first arrangement of the arms 308, 310, 312, 314, 316, 318 and legs 330, 332, 334, 350, 352, 354 within the head 302 of the embolic filter 300. In order to minimize the invasion of the patient during the installation of the embolic filter 300, it may be desirable to minimize the outer diameter of the head 302 of the embolic filter 300. Minimizing the outer diameter can result in a minimized internal diameter of the embolic filter 300. In order to fit within the head 302, the arms 308, 310, 312, 314, 316, 318 and legs 330, 332, 334, 350, 352, 354 can be arranged as shown in
(50) For example, the bent legs 330, 332, 334, e.g., the proximal ends thereof, can be arranged around the center of the head, e.g., the point through which the longitudinal axis (not shown in
(51) Thereafter, the proximal ends of the first and second bent arms 308, 310 can be placed adjacent to each other within a first space 912 bound by the first straight leg 350, the second bent leg 332 and the second straight leg 352. The proximal ends of the third and fourth bent arms 312, 314 can be placed adjacent to each other within a second space 914 bound by the second straight leg 352, the third bent leg 334 and the third straight leg 354. Moreover, the proximal ends of the fifth and sixth bent arms 316, 318 can be placed adjacent to each other within a third space 916 bound by the third straight leg 354, the first bent leg 330 and the first straight leg 334.
(52) Referring to
(53) The proximal end of the first bent leg 330 can be placed in contact with the proximal end of the first straight leg 350 and the proximal end of the second straight leg 352. The proximal end of the second bent leg 332 can be placed in contact with the proximal end of the second straight leg 352 and the proximal end of the third straight leg 354. Further, the proximal end of the third bent leg 334 can be placed in contact with the proximal end of the third straight leg 354 and the proximal end of the first straight leg 350. As such, the centers of the bent legs 330, 332, 334 also form an equilateral triangle. Further, the proximal end of the first straight leg 350 can be placed in contact with the proximal end of the first bent leg 330 and the proximal end of the second bent leg 332. The proximal end of the second straight leg 352 can be placed in contact with the proximal end of the second bent leg 332 and the proximal end of the third bent leg 334. Also, the proximal end of the third straight leg 354 can be placed in contact with the proximal end of the third bent leg 334 and the proximal end of the first bent leg 330.
(54) Thereafter, the proximal ends of the first and second bent arms 308, 310 can be placed on each side of the proximal end of the first bent leg 330 so that the proximal ends of the first and second bent arms 308, 310 flank the proximal end of the first bent leg 330. The proximal ends of the third and fourth bent arms 312, 314 can be placed on each side of the proximal end of the second bent leg 332 so that the proximal ends of the third and fourth bent arms 312, 314 flank the proximal end of the second bent leg 332. Moreover, the proximal ends of the fifth and sixth bent arms 316, 318 can be placed on each side of the proximal end of the third bent leg 334 so that the proximal ends of the fifth and sixth bent arms 316, 318 flank the proximal end of the third bent leg 334.
(55) Conclusion
(56) With the configuration of structure described above, one or more of the embodiments described herein can provide a device that can be permanently or temporarily installed within a patient, e.g., within an inferior vena cava of a patient. The embodiments described herein can include a plurality of bent arms that provide lateral stability and maintain the embolic filter substantially centered within the inferior vena cava. Further, features of the embodiments described herein can include a plurality of bent legs that extend in generally the same direction as the bent arms. Each bent leg can include a foot that can be formed with a hook or a barb. The feet of the bent legs can engage the inner wall of the inferior vena cava and can substantially prevent cranial migration of the embolic filter.
(57) Moreover, the embodiments described herein can include a plurality of straight legs. Each straight leg can include a vein engagement face that can engage the inferior vena cava in a direction opposite the feet of the bent legs. The vein engagement faces can prevent caudal migration of the embolic filter. Accordingly, when the embolic filter is placed within the inferior vena cava it can remain substantially within the original location in which it is placed until it is removed.
(58) The embolic filter, as described herein, includes six arms and six legs. It can be appreciated that the embolic filter can include more or less than six arms and more or less than six legs. Further, the embolic filter, as described herein, includes three bent legs and three straight legs. However, the embolic filter can include other combinations of bent legs and straight legs, e.g., four bent legs and two straight legs, two bent legs and four straight legs, etc. Also, the straight legs can be formed similar to the bent legs, e.g., with a bend, while retaining the relatively larger diameter. Additionally, one or more of the arms can be formed similar to the straight legs, e.g., with or without a bend, with an enlarged distal end, with a vein engagement face, or a combination thereof.
(59) The above-disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments that fall within the true spirit and scope of the present invention. Thus, to the maximum extent allowed by law, the scope of the present invention is to be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be restricted or limited by the foregoing detailed description.