Blocking body

Abstract

The invention relates to a cylindrical occlusion body for sealing a hollow cylindrical body vessel, which occlusion body can be positioned in a contracted state in a minimally invasive manner and can be converted into an expanded state in which the occlusion body has a widened diameter for bearing on an inner wall of the body vessel, the occlusion body (1) comprising a wire mesh (4), the invention relates to a closure body (1) comprising a wire web (2) of which the wires are brought together at their ends such that the closure body (1) forms a cage in the expanded state, characterized in that the closure body has a sail-shaped insert (6) enclosed within the closure body and oriented longitudinally, the sail-shaped insert comprising one or more elongated wire loops (11, 12) arranged in a row, the proximal ends of the wire loops are fixed at the proximal end of the occlusion body (1), each of the wire loops being covered with a membrane.

Description

Technical Field

[0001] The present invention relates to a cylindrical occluder for sealing hollow cylindrical blood vessels in the body, the cylindrical occluder being positioned in a contracted state with minimal invasiveness and being able to be converted into an expanded state, in which the occluder has a widened diameter for support on the inner wall of the blood vessel, wherein the occluder comprises a mesh of wires, the wires of the mesh being joined together at their ends such that the occluder forms a cage in the expanded state. Background Technology

[0002] A common practice is to implant an obstruction body into a blood vessel in a minimally invasive manner to stop blood flow. This is used, for example, to close blood vessels, fistulas, or shunts between blood vessels in cancer treatment, aneurysms, or to close the left atrial appendage to prevent thrombosis. Various variants of obstruction bodies have been developed for this purpose.

[0003] For example, an occluder in the form of a double-shielded occluder is known from EP 0 808 138 B1. This occluder is made of a metal fabric composed of intertwined strands of metal cord. The occluder is placed at the desired location in the patient's vascular system using a catheter, and the occluder is then in an expanded state. Specifically, PFO is used for the occluder.

[0004] An occluder is known from DE 10 2009 058 132 A1, which has a cylindrical cage structure and includes membranes assembled transversely to longitudinally within the cage, these membranes being suitable for inhibiting or stopping blood flow. Manufactured from a shape memory material, it allows for transport in a contracted state and placement in an extended state. A comparable occluder is described in WO 2013 / 005 195 A1.

[0005] It has been found that simple cage structures are rarely suitable for stopping unwanted blood flow. Inserting the occlusive membrane transversely to the longitudinal direction of the obstruction is problematic—generally, the membrane must be laboriously sewn in. After placement, the transversely installed membrane can be released by the expansion or tension of the cage, leaving the expansion and thus closure of the vessel incomplete. Summary of the Invention

[0006] Therefore, the object of the present invention is to provide an occluder with a cage structure, which is suitable for adequately inhibiting blood flow in a blood vessel after implantation. An internally inserted membrane may not inhibit the expansion of the occluder during implementation.

[0007] This objective is achieved by a cylindrical plug of the type indicated at the beginning, wherein the plug has a sail-shaped insert that is enclosed within the plug and oriented longitudinally, the sail-shaped insert comprising one or more elongated filament loops arranged in a row, the proximal ends of these filament loops being fixed at the proximal ends of the plug, wherein each of the filament loops is covered with a membrane.

[0008] According to the present invention, the term distal side refers to the side of the implant that is away from the treating physician, and proximal side refers to the side that is facing the treating physician.

[0009] A cage should be understood as a woven enclosure that is closed on all sides, wherein the ends of the net's threads are joined together at two longitudinal ends.

[0010] A thread loop should be understood as a longitudinally elliptical thread structure consisting of a single thread whose ends are joined and overlapped, or of two threads that are bent upwards and overlapped in each case. If multiple loops are arranged in a row, one or more threads are twisted together at least once to form a knot that separates the individual loops from each other. The surface surrounded by the loops is covered with a membrane.

[0011] The blocking body according to the invention has a generally cylindrical shape and is composed of a wire mesh. A material with shape memory properties (e.g., spring steel or nickel-titanium alloy, particularly nitinol) is used for the wire mesh. The wires of the wire mesh are joined together at both ends to create a closed cage. The ends of the wires are conveniently secured in a medical steel cannula.

[0012] The occluder according to the invention is intended to be inserted into and implanted in a hollow cylindrical body blood vessel. Insertion occurs by means of a conventional catheter or sheath, wherein the occluder is transported in a contractile form. For this purpose, the occluder is connected to a provided introduction system that allows the occluder to be pushed out of the catheter, brought to its intended location, and released at its intended location. Once released, the occluder expands into a predetermined cylindrical shape and is supported against the inner wall of the corresponding body blood vessel with its widened diameter. This expansion is also associated with the opening of a sail-shaped insert that extends longitudinally within the cage.

[0013] The sail-shaped insert within the obstruction body preferably consists of at least two filament loops having a longitudinal / elliptical orientation, each loop being covered by a membrane. The filament loops can be composed, on the one hand, of a single monofilament folded back and with its ends overlapping, and on the other hand, of two monofilaments overlapping at their ends and interconnected via a membrane. To form loops arranged in a row, one or more filaments are twisted together at at least one point.

[0014] The sail-shaped insert is necessarily secured to the proximal end of the occluder via its proximal end. This can occur, for example, by sewing it to the proximal end of the occluder using suture material. Alternatively, the proximal suture end of the insert can be secured to the proximal suture end of the occluder within the proximal sleeve of the occluder. In both cases, a rigid connection is created, which is configured to be durable. The distal end of the sail-shaped insert remains freely movable and is not secured to the distal end of the occluder.

[0015] In general, biocompatible plastic materials are used as membrane materials, with Teflon or polyurethane being preferred.

[0016] According to one embodiment, the sail-shaped insert can have a longitudinally elliptical shape along its entire length, such as a lens shape. However, a preferred shape is one in which the insert is twisted multiple times at its center, thus forming two segments of approximately the same size, which are separated from each other by a twist knot. Another variation provides multiple twists, forming three or four loops or segments of approximately the same size that follow each other. For the twisting, the thread loops are preferably rotated multiple times (e.g., six times) to produce a stable structure. Preferably, these individual segments are not located in a single plane, but rather rotate more or less about each other.

[0017] The occluder according to the invention is positioned with a catheter or sheath in a known manner. For this purpose, the occluder is connected to a guidewire / introduction system that allows the occluder to be pushed out of the catheter, brought into the catheter, and released at its intended location. This preferably occurs in a known manner by means of a ball pin at the end of the guidewire or introduction system and grasping forceps. In the positioned state, the occluder is rigidly connected to the grasping forceps, i.e., the grasping forceps are closed. For release, the forceps are opened via a spring mechanism and the catheter and guidewire are retracted. The ball pin is suitably a ball, which is fixed (e.g., securely welded) to the proximal sheath of the occluder and held firmly by the forceps.

[0018] As already described, the sail-shaped insert is either connected to the proximal end of the occluder via a suture material thread or joined together via overlapping ends, wherein the end of the occluder is in the proximal cannula and curled there.

[0019] Furthermore, and particularly, the blocking body may be coated with a film on its end faces (at the proximal and / or distal ends), which is preferably a polyurethane or Teflon film. This type of film can be applied to the surface of the mesh, for example, by impregnation. Attached Figure Description

[0020] The invention will be explained in more detail with reference to the accompanying drawings, in which:

[0021] Figure 1 This is a plan view of the blocking body without the insert according to the present invention;

[0022] Figure 2 A sail-shaped insert for a surgical suture material with a proximal arrangement is shown;

[0023] Figure 3 yes Figure 2 A three-dimensional view of the sail-shaped insert; and

[0024] Figure 4 A blocking body according to the invention is shown, the blocking body having a sail-shaped insert indicated therein. Detailed Implementation

[0025] according to Figure 1 The occluder 1 according to the invention comprises a cylindrical wire mesh 4, the end wires of which are joined together and secured in sleeves 2 and 3. Sleeves 2 and 3 are coiled together around the ends of the wires to provide durable retention. The proximal sleeve 3 terminates in a pin having a ball 5 for securing the occluder 1 to a guidewire grasping forceps (not shown).

[0026] The filament mesh 4 of the occlusion body 1 is composed of a shape memory material, particularly nitinol, which allows the occlusion body to be transported within the catheter in a constricted state. After exiting the catheter, the occlusion body 1 expands and abuts against the inner wall of the vessel to be closed, with the periphery of the occlusion body widening. It remains fixed in position due to its expanding force.

[0027] The threads of the obstruction body 1 are joined together at the ends, causing the thread net 4 to solidify and thus making it suitable for inhibiting blood flow in the corresponding blood vessel.

[0028] Figure 2 A sail-shaped insert 6 with two threads 7, 8 is shown, which are rotated together multiple times at point 9 to form a knot. A suture 10 of surgical suture material at the proximal end of the insert 6 is used to secure it to the proximal end of the obstruction 1. The overlapping ends of the threads 7, 8 are not shown. A polyurethane film covering or membrane forms the sail-shaped structure, which, in the case shown, includes two loops or segments 11, 12.

[0029] The sail-shaped insert 6 is conveniently inserted into the blocking body 1 by passing it through the wire mesh 4, which, due to its shape memory properties, can easily expand and spring back to its predetermined shape after insertion. It is also possible to place it inside the blocking body 1 during manufacturing (i.e., before the proximal end is closed); in this case, the sail-shaped insert can be directly rolled to the wire end of the blocking body 1 and the sleeve 3.

[0030] Figure 3 yes Figure 2 A three-dimensional view of the sail-shaped insert. It is clear that the two sections of insert 6 do not extend in a single plane, but rather rotate about each other and simultaneously include protrusions.

[0031] Figure 4 A blocking body 1 according to the invention is shown, in which a sail-shaped insert 6 is arranged, and for clarity, the sail-shaped insert 6 is shown in two segments 11, 12 in a plane. Of course, the sail-shaped insert is fixed to the blocking body 1 only by its proximal end; the distal end is freely movable. This is necessary because the blocking body 1 has a small diameter and a significant length in its contracted state, which does not correspond to the length of the insert 6 in this state.

Claims

1. Cylindrical occlusion body for sealing a hollow cylindrical body vessel, which occlusion body can be positioned in a collapsed state with minimal invasion and can be converted into an expanded state in which the occlusion body has a widened diameter for bearing against the inner wall of the body vessel, wherein, The obstruction body (1) comprises a wire mesh (4), the wires of which are joined together at the ends of the wires, such that the obstruction body forms a cage in the expanded state, characterized in that the obstruction body (1) has a sail-shaped insert (6) which is enclosed within the obstruction body (1) and is oriented longitudinally, the sail-shaped insert (6) comprising one or more elongated wire loops (11, 12) arranged in a row, the proximal ends of the wire loops (11, 12) being fixed at the proximal end of the obstruction body (1), wherein each of the wire loops is covered with a membrane.

2. The cylindrical obstruction of claim 1, wherein, The wire mesh (4) consists of a material with shape memory properties, in particular Nitinol.

3. A cylindrical obstruction according to claim 1 or claim 2, characterised in that, The ends of the obstruction body (1) are joined together with sleeves (2, 3) consisting of medical steel.

4. A cylindrical obturator according to claim 3, wherein, The proximal sleeve (8) is provided with a ball pin (5).

5. Cylindrical obstruction according to any of the preceding claims, characterized in that The wires (7, 8) of the wire loops (11, 12) consist of a shape memory material, in particular Nitinol, and are folded together at the ends.

6. Cylindrical obstruction according to any of the preceding claims, characterized in that The wires (7, 8) are twisted to form two loops (11, 12), resulting in two sail-shaped sections.

7. The cylindrical obstruction of any one of claims 1 to 5, wherein, The wires (7, 8) are twisted to form three or more loops.

8. Cylindrical obstruction according to any of the preceding claims, characterized in that The membrane consists of Teflon or polyurethane.

9. Cylindrical obstruction according to any of the preceding claims, characterized in that The proximal ends of the wire loops (11, 12) are joined together and fixed together with the proximal end of the obstruction body.

10. The cylindrical obstruction of any one of claims 1 to 8, wherein, The sail-shaped insert (6) is fixed to the proximal end of the obstruction body (1) using a suture material (10).

11. Cylindrical obstruction according to any of the preceding claims, characterized in that The proximal end and / or the distal end of the obstruction body (1) is coated with a membrane. The proximal end and / or the distal end of the obstruction body (1) is coated with a membrane.

Images