RU206863U1 - OKKLUDER - Google Patents

Abstract

The utility model relates to the field of medicine, in particular, to medical technology, and can be used to close the lumen of a vessel. The occluder for closing the lumen of the vessel is made in the form of a tubular structure of a stent with proximal and distal ends. The tubular structure is configured to collapse in a collapsed state for delivery to the target site of the vessel and return to the expanded configuration within the target site. The tubular structure is made in the form of a balloon-expandable stent with a narrowed section 3 at the distal end in an open configuration, while inside the stent there is a tube 2 made of a sealing material, fixed on the stent beams along the perimeter of the proximal edge and immediately in front of the narrowed section 3 at the distal end, and the free section 4 of the tube made of sealing material is tucked inside the specified tube 2 in the direction of the proximal end of the stent frame relative to the place of fixation at the distal end of the stent frame 1. The technical problem solved by the present utility model is to propose a reliable design of an occluder that does not require a delivery catheter to be inserted into the implantation area. To achieve the technical result, which consists in the possibility of advancing the occluder along the guidewire, as a conventional balloon-expandable stent is delivered, said occluder is made in the above manner. 8 ill.

Description

Technical field to which the utility model belongs

The utility model relates to the field of medicine, in particular, to medical technology, and can be used to close the lumen of a vessel.

State of the art

Various methods and devices for artificial occlusion of the vascular bed for therapeutic purposes are known from the prior art. In particular, intravascular occlusion devices are known for selectively closing a vessel anywhere in the body's circulatory system where it is desired to shut off blood flow. Typically, these devices are suitable for delivery via a catheter to a remote site in a patient's vascular system.

Mechanical embolization devices for closing vessels at various locations in the vasculature are well known in the art and commercially available. Patent 6,123,715 by Amplatz and Patent 5,725,552 by Kotula propose intravascular occlusion devices made from a braided metal structure of Nitinol that are heat stabilized in expanded molds, but which can be compressed for delivery via a catheter to the site of treatment, as a result of which the device, when pushed out of the delivery catheter, self-expands in the vasculature to block blood flow at the site of treatment. Detailed descriptions of various designs and configurations, as well as methods of making and using the devices, are given in the aforementioned patents.

It is also known an intravascular occlusion device comprising a plurality of metal strands woven into a tubular braided metal structure having a proximal end and a distal end, wherein at least one of said ends comprises means connected to the tubular braided metal structure for securing said end , and thus for collecting said strands and restraining untwisting of strands, said tubular braided metal structure having an expanded predetermined configuration adapted to occlude a hole in the body, wherein said expanded predetermined configuration comprises a disc-shaped first portion of a first diameter on, along at least one of the proximal and distal ends, designed to abut the adjacent wall surrounding the specified hole, and an adjacent cylindrical second section of the second diameter, intended to be placed inside the specified hole, when than the first and second sections are connected by a flexible transition section having a diameter that is smaller than both the first and second diameters, and the device is configured to deform to a smaller size in cross-section for delivery along the channel in the patient's body, and the braided metal structure has a memory property, whereby the medical device tends to return to said expanded preset configuration when in a free state. Patent RU 2432 128, publ. 27.10.2011.

Also known and widely used are occluders for embolization of peripheral vessels, such as AMPLATZER Vascular Plug, AMPLATZER Vascular Plug II, AMPLATZER Vascular Plug III and AMPLATZER Vascular Plug IV, which are delivered to the insertion site via a catheter.

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The disadvantage of the devices known from the prior art is that all of them are delivered to the target section of the vessel through a delivery catheter, which must be placed in the region of the target final position of the occluder, which significantly complicates delivery of the device through the tortuous sections of the vessel, and is fraught with displacement of the complex during implantation. “Delivering catheter - occluder” and, as a result, non-target embolization.

Disclosure of a utility model

The technical problem solved by the present utility model is to propose a reliable occluder design that does not require a delivery catheter to be inserted into the implantation area during its installation.

To achieve the technical result, which consists in the possibility of advancing the occluder along the guidewire, as a conventional balloon-expandable stent is delivered, said occluder is made as follows.

According to the utility model, the occluder for occluding the lumen of the vessel is made in the form of a tubular structure with proximal and distal ends, the tubular structure being configured to collapse in a folded state for delivery to the target region of the vessel and return to the open configuration within the target region. The tubular structure is made in the form of a balloon-expandable stent with a narrowed section at the distal end in an open configuration, while a tube made of a sealing material is placed inside the stent, fixed on the beams of the stent frame along the perimeter of the proximal edge and immediately in front of the narrowed section at the distal end. The free section of the tube made of sealing material is tucked inside the specified tube in the direction of the proximal end of the stent frame relative to the place of fixation at the distal end of the stent frame.

The specified occluder is made as follows:

- a stent is made, the structure of the distal end of which does not allow the specified end to open up to the level of the opened configuration of the main part of the stent;

- a tube made of a sealing material is placed inside the stent;

- fix the specified tube on the beams of the stent along the perimeter of the proximal edge and immediately in front of the narrowed area at the distal end;

- the free section of the tube made of the sealing material is tucked inside the specified tube in the direction of the proximal end of the tubular stent frame relative to the fixation point at the distal end of the tubular stent frame,

- the occluder is squeezed into the folded state on the balloon catheter of the delivery system.

Delivery of the above-described occluder to the target site of the vessel is carried out by its advance to the specified site along the guidewire as a balloon-expandable stent.

Thus, the design described above provides the achievement of the above technical result, which consists in the possibility of moving the stent-occluder along the guidewire, as a conventional balloon-expandable stent is delivered,

The above provides the device with good delivery and guaranteed targeted implantation in place.

Brief Description of Drawings

The utility model is illustrated by drawings.

FIG. 1 shows a view of an occluder in an open configuration according to the invention;

in fig. 2a, 2b - stages of making an occluder according to the utility model;

Fig. 3 is an occluder delivery system;

in fig. 4 is a view of the occluder in a compressed state on the delivery system;

in fig. 5 is a view of the occluder in an open configuration under the action of a specially shaped balloon catheter of the delivery system;

in fig. 6a, 6b - overlap of the vessel lumen under the influence of blood flow.

Implementation of the utility model

The basis of the device is a balloon-expandable bare metal stent (made like all modern stents from steel 316L or from a cobalt-chromium alloy according to the technology known to specialists in this field). The design feature of this stent is the design of the distal "crown" of the stent, which does not allow the stent to open more than 1/3 of the reference values of the diameter of the entire device.

Another feature of this device is the balloon delivery catheter. The delivery system can be made in three known versions: 1. to have a lumen for the guide throughout the entire length - OTW type. 2. Have a lumen for the guide wire only along the distal part of the balloon catheter shaft - type RХ, or 3. have only one lumen for filling the balloon with a contrast agent, with a fragment of the guide wire on the distal part of the balloon. A special feature is the bottle shape of the balloon: when the main diameter of the balloon has a reference target value, and its distal part (1/3 or ¼ of the balloon length) has a minimum technological diameter and serves not to open the stent to the required diameter, but only to provide the possibility of unimpeded removal of the delivery balloon from the stent lumen.

The delivery system 9 in the present device is a balloon compliant balloon catheter 7 of rapid exchange (RX) or OTW (over the wire) systems on conductors of known diameters 0.014 - 0.018 - 0.021 - 0.35 Fr or a single lumen balloon catheter in which the guide segment is fixed to the distal tip of the balloon. The only design feature of the balloon 8 of the delivery system of this device is its shape in the form of a bottle, in which the diameter of the distal part of the balloon catheter (bottleneck) has the minimum diameter necessary for the minimum deployment of the device from the distal end necessary to create conditions for the unhindered release of the delivery system from the lumen of the opened implanted devices. This balloon shape is not unique. There are examples of the existence on the market of balloon catheters of various forms: bottle - for the delivery system of specialized so-called. bifurcation stents; balloon catheters of conical shape with a smooth difference in diameter from the proximal to the distal end.

Manufacturing and assembly of the device:

The manufacture and assembly of the device is shown in FIG. 2a and 2b.

The first step is the introduction of a seamless tube 2 made of non-woven material (for example, PTFE) into the lumen of the open frame 1 of the stent.

The second stage is the fastening 5, 6 of the tissue to the stent frame 1 in diameter along the proximal perimeter of the frame 1 and in the central part of the frame 1 closer to its distal end, further narrowed section 3.

The third stage is tucking (intussusception) of the distal free and non-fixed part 4 of the tissue tube 2 inside the part fixed to the frame 1 of it.

The fourth stage: positioning of the occluder on the balloon 8 of the delivery system 9 and its compression (Fig. 4).

Sealing fabric material

Traditional nonwoven materials (based on PTFE, etc., which are used for stent grafts or for internal filling of plug-type nitinol occluders) can be used, including composite ones - multilayer in which the outer layer is sealing, and the inner (edge) causes increased thrombogenicity ( as on some embolizing coils). The fabric for the device is used as a seamless tube. It is cut in length 1.2-1.8 times exceeding the length of the stent. It is inserted into the opened frame stent and fixed to the stent bars along the perimeter of the proximal edge and immediately in front (proximal) of the narrow section of the structure. The remaining unfixed part is tucked circularly inward like an invaginate (duplicate) and further serves as a closure of the vessel lumen, preventing blood flow 10. Complete eversion of the tissue along the blood flow is prevented by a narrow part of the frame, which opens only until the balloon catheter of the delivery system can be removed.

Assembled devices provide the ability to:

1. Delivery to the place of implantation into the lumen of an artery or vein with a diameter of 2.5 mm to 12 mm of an occluder of the corresponding diameter when folded on the delivery system - on a balloon catheter. Delivery is via a guide wire through the lumen of the guide catheter or through a guide wire without a guide catheter.

2. Deployment of the occluder to the desired shape and size by inflating the balloon catheter of the delivery system.

3. Removal of the delivery system balloon catheter from the lumen of the implanted occluder and from the target vessel.

The device is designed for vessels with a diameter of up to 12 mm and can be made for vessels less than 3 mm in diameter, which is not in the model range of existing analogues, which in their total mass are oriented towards a larger size.

Claims (1)

An occluder for closing the lumen of a vessel, made in the form of a tubular structure with proximal and distal ends, while the tubular structure is configured to be collapsed in a folded state for delivery to the target region of the vessel and return to the open configuration within the target region, characterized in that the tubular structure is made in in the form of a balloon-expandable stent with a narrowed section at the distal end in an open configuration, while a tube of sealing material is placed inside the stent, fixed on the beams of the stent frame along the perimeter of the proximal edge and immediately in front of the narrowed section at the distal end, and the free section of the tube is made of sealing material is tucked inside the specified tube in the direction of the proximal end of the stent frame relative to the place of fixation at the distal end of the stent frame.

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