CN107137160B

CN107137160B - Bidirectional controllable release filter for preventing displacement

Info

Publication number: CN107137160B
Application number: CN201710318183.5A
Authority: CN
Inventors: 张庭超; 李阳
Original assignee: Hangzhou Weiqiang Medical Technology Co Ltd
Current assignee: Hangzhou Endonom Medtech Co Ltd
Priority date: 2017-05-08
Filing date: 2017-05-08
Publication date: 2021-06-11
Anticipated expiration: 2037-05-08
Also published as: CN107137160A

Abstract

The invention discloses a bidirectional controllable release filter for preventing displacement, which comprises a first filter part and a second filter part, wherein the openings of the first filter part and the second filter part are opposite; the first filter part is formed by gradually extending outwards from the center in a forward direction and gradually turning and curling in a reverse direction, and the first filter part is supported on the inner wall of the blood vessel; the second filter part is formed by extending the center outwards gradually; the first filtering part is provided with an anchoring thorn which extends reversely and is used for anchoring on the inner wall of the blood vessel, and the second filtering part is provided with an anchoring thorn which extends forwardly and is used for anchoring on the inner wall of the blood vessel. The present invention provides a bi-directional controlled release filter that can be implanted and retrieved through both the femoral and jugular veins, the filter having bi-directional anchors that prevent both forward and reverse displacement.

Description

Bidirectional controllable release filter for preventing displacement

Technical Field

The invention belongs to the technical field of medical instruments, relates to a filter, and particularly relates to a bidirectional controllable release filter capable of preventing displacement.

Background

Pulmonary Embolism (PE) is a common health problem and an important factor in death in all age groups. Most pulmonary embolisms are caused by Deep Vein Thrombosis (DVT) in the lower limb or pelvis, by which blood clots may migrate through veins back to the heart and into the lungs, resulting in a pulmonary infarction due to loss of blood and oxygen supply to a portion of the lungs.

In current treatment protocols, the use of filters can prevent and reduce the occurrence of pulmonary embolism with anticoagulation contraindications or ineffective anticoagulation. The filter is generally delivered to the inferior vena cava from the femoral vein, but when floating thrombus exists in the double iliac vein or the inferior vena cava, the filter needs to be implanted into the inferior vena cava from the superior vena cava through the right atrium through the jugular vein or the antecubital vein, so that an ideal inferior vena cava filter can be implanted and recovered through the femoral vein and can also be implanted and recovered through the jugular vein, namely the filter is released into the blood vessel through two directions of the neck and the transfemoral vein in a controllable release mode, the filter needs to be implanted into a specific position of the inferior vena cava vessel in the operation process, the position of the filter release is not required due to misoperation and the like in the operation process, and the filter needs to be retracted into a delivery sheath again to be repositioned and released in the operation process, and the filter is called controllable release.

In the prior art, a common vena cava filter with a cage-shaped structure has the defects that the filter can only be released controllably in one direction through a femoral vein, and if the filter is released through a jugular vein, after the filter is pushed out from a delivery sheath, an anchor thorn is arranged along the blood flow direction, the opening direction of the anchor thorn faces the direction of the delivery sheath, so that the filter is difficult to be taken in the delivery sheath again through the jugular vein and cannot be released again.

There is also a common vena cava filter of a tapered strut structure, which is implanted in the inferior vena cava like a funnel for filtering thrombus, and the opening of the funnel faces the blood stream only to effectively intercept thrombus, and the filter has the following disadvantages: due to the directionality of the conical structure, the filter can only realize controllable release when being implanted through the jugular vein, and when being released through the femoral vein, the filter can not be recycled into the sheath once being pushed out of the sheath, and can be positioned and released again.

Disclosure of Invention

The invention aims to solve the technical problem that the filter in the prior art can only realize one-way controllable release, and provides a two-way controllable release filter which can be implanted and recovered through a femoral vein and a jugular vein, and has two-way anchoring thorns to prevent positive and reverse displacement.

The technical scheme adopted by the invention for solving the technical problems is as follows: a displacement-preventing, bi-directional controlled release filter comprising first and second oppositely-opening filter sections;

the first filter part is formed by gradually extending outwards from the center in a forward direction and gradually turning and curling in a reverse direction, and the first filter part is supported on the inner wall of the blood vessel;

the second filter part is formed by extending the center outwards gradually;

the first filtering part is provided with an anchoring thorn which extends reversely and is used for anchoring on the inner wall of the blood vessel, and the second filtering part is provided with an anchoring thorn which extends forwardly and is used for anchoring on the inner wall of the blood vessel.

In the above-mentioned bidirectional controlled release filter for preventing displacement, it is preferable that a plurality of struts extend from the same center to form a second filter portion having a forward opening and a first filter portion having a reverse opening, respectively.

In the bidirectional controllable release filter for preventing displacement, preferably, the first filter part and the second filter part are of an integral structure, the first filter part and the second filter part extend and are cross-linked from the same center through a strut, cross-linking points of the cross-linked struts are respectively turned over and curled reversely to form the first filter part, and the cross-linked struts extend outwards gradually in the forward direction to form the second filter part.

In the bidirectional controllable release filter for preventing displacement, the first filter part and the second filter part are preferably arranged at intervals and connected through a connecting rod.

In the above-mentioned bidirectional controlled release filter for preventing displacement, it is preferable that the anchor of the first filter unit is disposed on the outermost side of the first filter unit.

In the bidirectional controllable release filter for preventing displacement, preferably, the first filter part is formed by uniformly arranging at least three support rods along the central axis, and the anchoring thorn is at least arranged on one support rod and is positioned at the farthest point of the support rod away from the central axis.

In the bidirectional controllable release filter for preventing displacement, the anchoring thorn of the second filter part is preferably arranged at the tail end of the strut of the second filter part and is formed by extending the tail end of the strut;

or the anchor thorn of the second filter part is positioned at the farthest point of the support rod from the central axis and forms a branched structure with the tail end of the support rod.

In the anti-displacement bidirectional controllable release filter, an included angle alpha between an anchor thorn of the first filter part and a central axis is preferably 0-90 degrees; the included angle beta between the anchor thorn of the second filtering part and the central axis is 0-90 degrees.

In the bidirectional controllable release filter for preventing displacement, the length of the anchoring thorn of the first filter part and the length of the anchoring thorn of the second filter part are both preferably less than 6 mm.

In the above bidirectional controlled release filter for preventing displacement, it is preferable that the first filter unit and/or the second filter unit is/are connected to a recovery unit.

The invention adopts the first filter part and the second filter part with opposite openings to realize bidirectional controllable release, namely the filter can be implanted through a strand and recovered through the strand, and also can be implanted through a neck and recovered through the neck, and meanwhile, when the implantation position is not correct or the implantation state is not ideal, the filter can be directly recovered into the sheath tube to perform positioning and implantation again. Meanwhile, no matter the filter is implanted through the neck or the thigh, the filter has bidirectional anchoring thorns, and can prevent positive and reverse displacement. Meanwhile, the anchor stabs arranged in two directions at different positions are not easy to kink, and the filter can be smoothly unfolded in the body.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic structural view of embodiment 1 of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1 at A;

FIG. 3 is an enlarged view of a portion of FIG. 1 at B;

FIG. 4 is a schematic view showing an implantation state of a first vascular implantation method according to example 1 of the present invention;

FIG. 5 is a schematic view showing an implantation state of a second vascular implantation method according to example 1 of the present invention;

FIG. 6 is a schematic structural view of embodiment 2 of the present invention;

FIG. 7 is a schematic structural view of embodiment 3 of the present invention;

FIG. 8 is a top view of embodiment 3 of the present invention;

fig. 9 is a perspective view of embodiment 3 of the present invention.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

Orientation definition: of the two axial directions, the direction defined from the first filter portion to the second filter portion is a forward direction and the opposite direction is a reverse direction, the forward direction and the reverse direction being relative to the filter itself regardless of the position and the direction in which the filter is implanted in the blood vessel. The central axis refers to the central axis of the whole filter and is also the central axis of the first filter part and the second filter part.

Example 1, as shown in fig. 1-5, a bi-directional controlled release filter for preventing migration includes a first filter portion 1200 and a second filter portion 1100 having opposite openings; the first filter part 1200 is formed by extending outward from the center forward direction gradually and turning and curling reversely gradually, and the first filter part 1200 is supported on the inner wall of the blood vessel; the second filter part 1100 is formed by extending outward from the center in a forward direction; the first filter part 1200 is provided with the anchoring thorn 1500 which extends reversely and is used for anchoring on the inner wall of the blood vessel, and the second filter part 1100 is provided with the anchoring thorn 1500 which extends forwardly and is used for anchoring on the inner wall of the blood vessel.

There are various positional relationships between the first filter portion 1200 and the second filter portion 1100: the filter comprises an integral structure, a split structure, a first filter part 1200 and a second filter part 1100 which extend from the same center, and the first filter part 1200 and the second filter part 1100 which respectively extend from the center at different positions.

In this embodiment, as shown in fig. 1, the first filter portion 1200 and the second filter portion 1100 have the same center, the first filter portion 1200 and the second filter portion 1100 are respectively composed of a plurality of

struts

1200a and 1100a, that is, one ends of the plurality of struts 1200a and one ends of the plurality of struts 1100a are gathered together to form the center, and the plurality of struts 1200a and the plurality of struts 1100a respectively extend from the same center to form the second filter portion 1100 with a forward opening and the first filter portion 1200 with a reverse opening. The first filter part 1200 and the second filter part 1100 formed at the same center can be divided into two cases, one is that the first filter part 1200 and the second filter part 1100 are integrated, and the second is that the two are assembled separately.

The first filter part 1200 and the second filter part 1100 of this embodiment are integrated, and the integrated structure is made by integral molding, and is formed by laser cutting and heat setting of a die of an od2.0mm nickel-titanium tube.

The first filter portion 1200 and the second filter portion 1100 have a cross-linked structure 1400, and the cross-linked structure 1400 is preferably formed by extending and cross-linking a plurality of

struts

1200a and 1100a from the same center, and cross-linking points 1401 formed by cross-linking the

struts

1200a and 1100a are respectively turned and curled in a reverse direction to form the first filter portion 1200 and extended outward in a forward direction step by step to form the second filter portion 1100. That is, a plurality of

struts

1200a and 1100a extend from a center, and first extend in a forward direction, the extended

struts

1200a and 1100a are cross-linked with each other, the

cross-linked struts

1200a and 1100a extend in a forward direction or a reverse direction from a cross-linking point 1401, the struts 1200a of the first filter unit 1200 and the struts 1100a of the second filter unit 1100 are staggered in an axial direction, that is, one strut 1100a extends in a forward direction and the other strut 1200a is turned over in a reverse direction, and the plurality of

struts

1200a and 1100a are staggered one by one to form the first filter unit 1200 and the second filter unit 1100.

The cross-linked structure 1400 is formed by a plurality of

struts

1200a and 1100a connected by nodes that are fixed or crossed at a distance to form a sheet or other circumferentially extending shape. In this embodiment, the

multiple struts

1200a and 1100a extend outward from the center, and have an angular or rhombic lattice structure formed by mutual cross-linking and gradually expanding diameters, and the lattice structure can be radially extended and contracted and is suitable for being accommodated in a sheath. The cross-linked structure 1400 can enhance the filtering effect and improve the structural stability of the filter.

The supporting rods 1200a of the first filtering portion 1200 have a corresponding axisymmetric structure, and are point-supported on the inner wall of the blood vessel, so that the inclination of the instrument can be prevented, and the wall adhesion of the recovery portion can be prevented. The first filtering portion 1200 is composed of at least three support rods arranged in axial symmetry, a plurality of support rods 1200a extend outwards and turn reversely gradually to form a support structure with a collection space with a reverse opening, the support rods 1200a are supported on the inner wall of the blood vessel, and the support points reduce the endothelial climbing. The number of the struts 1200a of the first filter portion 1200 is at least three, and six struts 1200a are adopted in the present embodiment and are arranged in an axisymmetric manner with respect to the central axis.

The included angle between the end of the strut 1200a or the tangent line of the end of the strut of the first filter portion 1200 and the central axis of the support portion is equal to or greater than 180 °, and the maximum outer diameter D of the first filter portion 1200 (the maximum outer diameter refers to the diameter of a circle formed by the farthest point of the strut relative to the central axis, D: the distance between the farthest point of the strut 1200a relative to the first central axis and the first central axis is twice) matches the inner diameter of the blood vessel so that the point of the strut 1200a is supported on the inner wall 2000 of the blood vessel. In the releasing process, the supporting rod 1200a stretches in the blood vessel, and no matter what structure the supporting rod 1200a has, after the releasing is finished, the included angle between the tangent line of the tail end of the supporting rod 1200a or the tail end of the supporting rod 1200a and the central axis is more than or equal to 180 degrees, so that the tail end of the supporting rod 1200a is staggered with the inner wall 2000 of the blood vessel and is at least in a state of being parallel to the inner wall 2000 of the blood vessel, and the end part of the supporting rod 1200a cannot puncture.

Point support is a relative concept in that the strut 1200a contacts the inner vessel wall 2000 with a relatively small contact area, i.e., contact with the inner vessel wall 2000 can be considered to be point support with respect to the length and diameter of the strut 1200 a.

As shown in fig. 1, the second filtering portion 1100 is composed of at least three struts 1100a arranged in axial symmetry, a plurality of struts 1100a extend outward in the forward direction to form a supporting structure of a collecting space with an opening in the forward direction, and the structure of the second filtering portion 1100 has various embodiments, and may be a single-layer strut structure or a multi-layer strut structure. In this embodiment, as shown in fig. 1, the second filtering portion 1100 adopts a single-layer strut structure, the single-layer strut structure is that a plurality of struts 1100a are uniformly arranged around the central axis, the shape and the structure of the struts 1100a are the same, the number of the struts 1100a is set as required, 6 struts 1100a are arranged in this embodiment, the shape of the strut 1100a can be a straight rod extending outwards or a curved rod with a certain radian, the curved rod can reduce the adherence area of the strut, and prevent the endothelium from climbing over, the embodiment adopts the curved rod, the curved rod is concave towards the center in the middle of the strut 1100a, and the contact area between the strut 1100a and the inner wall of the blood vessel is avoided from being too large. The included angle between the supporting rod 1100a and the central axis of the instrument is larger than 0 and smaller than 90 degrees, and the specific size of the included angle is set according to actual requirements.

The strut is provided with an anchoring spike 1500 for anchoring on the inner wall 2000 of the blood vessel, the anchoring spike 1500 of the present invention is provided on the first filter part 1200 and the second filter part 1100, respectively, and the anchoring spikes 1500 of the first filter part 1200 and the second filter part 1100 extend in opposite directions, which can prevent the filter from shifting in the forward direction or the reverse direction at the same time. Because the first filtering portion 1200 is formed by at least three supporting rods 1200a arranged uniformly along the central axis, the anchoring thorn 1500 of the first filtering portion 1200 is arranged on the outermost side of the first filtering portion 1200, that is, at least on one supporting rod 1200a and located at the farthest point of the supporting rod 1200a from the central axis. One anchor 1500 may be provided on one support rod 1200a, or two anchors may be provided on both sides of the support rod 1200a, respectively, to form two symmetrical anchors, and the two anchors 1500 of the first filter unit 1200 of the present embodiment are provided on both sides of the same support rod 1200a, and have the same extending direction and length. The included angle alpha between the anchor 1500 of the first filtering part 1200 and the central axis is 0-90 deg. As shown in fig. 2, in the present embodiment, the anchoring spike 1500 of the first filtering portion 1200 has an angle α of 46 ° with the central axis, and can be inserted obliquely into the inner wall of the blood vessel in the opposite direction.

The anchoring spike 1500 of the second filter house 1100 is disposed at the end of the strut 1100a of the second filter house 1100 and is formed by extending the end of the strut 1100a, or the anchoring spike 1500 of the second filter house 1100 is located at the farthest point of the strut 1100a from the central axis and forms a branched structure with the end of the strut 1100 a. The included angle beta between the anchor stinger 1500 of the second filtering portion 1100 and the central axis is 0-90 deg., in this embodiment, the anchor stinger 1500 of the second filtering portion 1100 is a bifurcate structure and is a double anchor stinger, the anchor stinger 1500 is disposed on two sides of the strut 100a, as shown in fig. 3, the included angle beta between the anchor stinger 1500 and the central axis is 39 deg., and the anchor stinger can be inserted into the inner wall of the blood vessel in a forward and oblique direction.

The filter displacement can be prevented by the anchor stabs 1500 of the first filter house 1200 and the anchor stabs 1500 of the second filter house 1100 in the forward and reverse directions, the length of the anchor stabs 1500 of the first filter house 1200 and the length of the anchor stabs 1500 of the second filter house 1100 are both less than 6mm, and in this embodiment, the length of the anchor stabs 1500 is 2.5 mm.

The first filter unit 1200 and/or the second filter unit 1100 are/is connected to the recovery unit 1300. The recovery unit 1300 is used for recovering the filter, and the recovery unit 1300 of the present embodiment is disposed at the center of the first filter unit 1200, and is fixedly connected to the first filter unit 1200 or is integrally formed with the first filter unit 1200. The recovery section 1300 includes a hook or loop for recovering the filter into the delivery conduit.

As shown in FIG. 4, the filter is shown in a schematic view in an implanted state after being delivered through the jugular vein, in which the space surrounded by the first filter portion 1200 is mainly used for capturing thrombus, and the anchor 1500 can prevent the forward and backward displacement of the device. First filter portion 1200 supports with blood vessel inner wall 2000 points, and the apparatus has better from central performance, prevents that the apparatus from inclining or retrieving the hook adherence, more is favorable to the apparatus to retrieve, when needs retrieve the filter, can catch the recovery hook of recovery portion 1300 through retrieving pipe and catcher from jugular vein puncture, retrieve whole filter to the sheath pipe to it is external to take out.

As shown in fig. 5, which is a schematic structural diagram of an implanted state after the filter is delivered through a femoral vein, at this time, a space surrounded by the second filter portion 1100 is mainly used for capturing thrombus, the first filter portion 1200 is supported by 2000 points on the inner wall of the blood vessel, and the device has better self-centering performance, prevents the device from inclining or a recovery hook from adhering to the wall, and is more beneficial to device recovery. The second filtering portion 1100 is in a bent shape, so that the supporting rod 1200a is prevented from adhering to the wall to the greatest extent, the endothelial climbing is reduced, and the anchor 1500 can prevent the forward and reverse displacement of the instrument. When the filter needs to be recovered, the whole filter can be recovered to the sheath from the femoral vein puncture through the recovery catheter and the capture hook, and taken out of the body.

Example 2, as shown in fig. 6, this example is an improvement on example 1, and differs from example 1 in that: the concentric first filter unit 1200 and the second filter unit 1100 are formed by separately combining them, and the first filter unit 1200, the second filter unit 1100, and the recovery unit 1300 are formed by molding and then combining them. While this example has no cross-linked structure.

In this embodiment, one anchoring spike 1500 of one strut 1200a of the first filtering portion 1200 is provided, and the angle α between the anchoring spike 1500 and the central axis is 21 °, so that the anchoring spike can be obliquely inserted into the inner wall of the blood vessel in the reverse direction. One anchoring thorn 1500 of the second filtering portion 1100 is arranged, the anchoring thorn 1500 is of a branched structure, an included angle beta between the anchoring thorn 1500 and the central axis is 72 degrees, and the anchoring thorn can be inserted into the inner wall of the blood vessel in a forward and oblique mode.

Example 3, as shown in fig. 7 to 9, this example is an improvement on example 1, and differs from example 1 in that: in this embodiment, the first filter portion 1200 and the second filter portion 1100 are disposed at an interval, and are connected to each other by a connection rod 1600.

The connection manner of the connection rod 1600 and the first filter portion 1200 and the second filter portion 1100 is as shown in fig. 7, and the connection rod 1600 is a tubular, rod-shaped or wire-shaped structure. The connecting rod 1600 may be integrated with at least one of the first filter house 1200 and the second filter house 1100, and the connecting rod 1600 may be formed by axially extending the center of the first filter house 1200 or the second filter house 1100 and bundling the two to form the connecting rod 1600. As shown in fig. 7 to 9, the struts 1200a of the first filter house 1200 and the struts 1100a of the second filter house 1100 are staggered in the axial direction for better filtering. I.e., the struts 1200a are axially located in the gaps between the struts 1100a, reducing the likelihood of thrombus leakage.

The positions of the first filter part 1200 and the second filter part 1100 are respectively located at two ends of the connecting rod 1600, and the opening of the first filter part 1200 and the opening of the second filter part 1100 may be opposite or opposite to each other. As shown in fig. 7, in the present embodiment, the openings of the first filter portion 1200 are opposite to the openings of the second filter portion 1100, forming an approximate cage structure.

In this embodiment, the anchor 1500 of the first filter portion 1200 forms an angle α of 19 ° with the central axis, and can be inserted obliquely into the inner wall of the blood vessel in the opposite direction. The anchor 1500 of the second filtering portion 1100 is a bifurcated structure, and has an included angle β of 41 ° with the central axis, so that the second filtering portion can be obliquely inserted into the inner wall of the blood vessel in the forward direction.

Claims

1. A bi-directional controlled release filter that resists displacement, comprising first and second oppositely opening filter sections;

the second filter part is formed by extending the center outwards gradually;

the first filtering part or/and the second filtering part is/are connected with the recovery part, and the gathering end of the first filtering part and the gathering end of the second filtering part are/is positioned at the same side of the recovery part;

the first filtering part is provided with an anchoring thorn which extends reversely and outwards and is used for anchoring on the inner wall of the blood vessel, and the second filtering part is provided with an anchoring thorn which extends forwards and is used for anchoring on the inner wall of the blood vessel;

the first filtering part is formed by uniformly arranging at least three supporting rods along the central axis, the anchoring thorn is at least arranged on one supporting rod and is located at the farthest point of the supporting rod from the central axis, and the free end of the supporting rod is opposite to the anchoring thorn and is curled inwards.

2. The migration resistant double action controlled release filter of claim 1, wherein said plurality of struts extend from a common center to form said second filter portion with a forward opening and said first filter portion with a reverse opening.

3. The filter of claim 2, wherein the first filter portion and the second filter portion are integrally formed and are cross-linked by a strut extending from a center, and the cross-linking points of the cross-linked strut are reversed and curled to form the first filter portion and forward and gradually extend outward to form the second filter portion.

4. The bi-directional controlled release filter against displacement of claim 1, wherein the first filter portion is spaced apart from the second filter portion and connected thereto by a connecting rod.

5. The migration resistant double release filter of any one of claims 1 to 4, wherein the anchoring of said first filter portion is disposed outermost of the first filter portion.

6. The migration resistant bilateral controlled release filter of any one of claims 1-4, wherein the anchors of the second filter portion are disposed at the strut ends of the second filter portion and are formed by extensions of the strut ends;

7. The anti-migration bilateral controlled release filter of any one of claims 1-4, wherein the angle α between the anchor stings of the first filter portion and the central axis is 0-90 °; the included angle beta between the anchor thorn of the second filtering part and the central axis is 0-90 degrees.

8. The migration resistant double release filter of any one of claims 1 to 4, wherein the anchoring length of both said first filter portion and said second filter portion is less than 6 mm.