RU2460500C1 - Device of implant for human and animal vessels - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely, to surgical instruments and can be applied in implanted devices for providing and supporting lumen of vessel or hollow organ. Implant device for human and animal vessels is made from material with shape memory in form of multi-coil body of rotation, connected with delivering device. Multi-coil body of rotation is made from flat pipe which has multiple perforation. Butt end of pipe are rigidly connected with formation of closed figure from doubled coils, terminal ones of which are connected between each other by rings. Coils are placed one to another without gap. Size of body of rotation in working condition corresponds to size of damaged region of vessel, and has form of cylinder or double-cone figure with the largest diameter in the middle. Terminal doubled coils of multi-coil body of rotation are bent by longitudinal axis with formation of loops. Delivering device for said implant is made in from of flexible catheter with tip, which is equipped with cut for connection with loop of coil of multi-coil body of rotation and face for safe removal of catheter.

EFFECT: reduction of vessel trauma during introduction and placement of claimed implant and safe provision with medicinal substance.

5 cl, 13 dwg

Description

The invention relates to medicine, namely to surgical instruments, and can be used in implantable devices to provide and maintain the lumen of a vessel or hollow organ.

Diseases of hollow organs, blood vessels are often accompanied by an abnormal expansion or narrowing or even complete blockage of the lumen, which leads to a decrease or complete loss of functional properties and the appearance of concomitant fatal consequences, such as bleeding. The use of an implant installed in the affected vessel allows the organ to return to working capacity and improve the general condition of patients. A promising direction in the creation of self-expanding implants in the form of stents when heated is their manufacture from nitinol or other material with shape memory. So, for example, an implant (stent) is described, made in the form of a three-dimensional body, the surface of which is formed by at least two groups of intertwined threads made of material with a shape memory effect and placed by multiple turns at an angle to each other in a helical spiral. The pitch of the turns of the threads is 0.5-10.0, and the diameter of the threads is 0.001-0.1 of the diameter of the volumetric body (SU 1812980, Schukin et al. 04/30/1993).

A known Danish implant design for stopping bleeding for varicose veins of the esophagus (http://www.stents.ru/doc/danis.pdf). It contains a self-expanding nitinol stent placed in the delivery system. This stent implant has a mesh wire netting, its ends are equipped with atraumatic steel loops and radiopaque markers, providing reposition and removal of the implant. The delivery system includes an inflatable balloon at the distal end and a steel conductor. It is known to use various coatings from drugs on the surface of the implant material to exclude inflammation and tissue ingrowth (RU 2360646 C2, DE SHIRDER et al., 10.07.2009).

Similar drugs are known in vascular surgery to expand the diameter of the arteries of the heart vessels (coronary), as well as in the treatment of diseases of the peripheral arteries and the restoration of normal blood flow through them. However, they must meet certain requirements, namely, be sufficiently elastic and flexible, have the property of radiopaque, the diameter of the lumen of the implant should be able to change, adapting to the state of the vessel.

In the patent US 4503569 (A), DOTTER CHARLES, 03/03/1985, an implant for prosthetics of a blood vessel is described, which is a tubular helical spiral made of metal with shape memory (nitinol alloy) having a transition temperature in the range of 46-52 ° C. After placement in a given place of narrowing of the blood vessel, the implant is heated to the transition temperature, it expands and is fixed to the inner wall of the vessel. After expansion, the diameter of the implant is approximately equal to the diameter of the passage of the blood vessel of the body.

A device of the implant for maintaining the lumen of a vessel created from a material biologically compatible with body tissues is known. This implant device is a wire frame in the form of a body of revolution, having a circular or rectangular cross section. The frame has the shape of a coil spring and is equipped with fixing elements to hold it on the delivery device to the vessel or hollow organ. The fixing elements are placed on both sides of the frame, and each of them is made in the form of a loop, one of which is in the initial section of the wire element, and the other in its final section. These loops are placed in a plane perpendicular to the axis of the skeleton in such a way that there is a partial overlap of the skeleton lumen, which can cause the formation of turbulent flows in the blood stream and, therefore, cause various complications in the form of, for example, thrombosis on them, leading to a decrease in the lumen of the vessel (SU 1237201 A1 06/15/1986).

The closest in design to the proposed one is the implant device, previously made in the form of a multi-turn spiral of nitinol wire, corresponding to the size of the prosthetic vessel associated with the delivery device for its installation (US 4512338 (A), BALKO ALEXANDER, 04.23.1985 - prototype). The implant is deformed to reduce its size, in a compressed state it is delivered to the installation site by a delivery device, subjected to heating, as a result of which it restores the desired shape, ensuring the maintenance of the lumen of the affected areas of blood vessels and hollow organs.

The disadvantage of this device is that it is formed from a wire with a medicinal substance deposited on it, which is lost during installation in the vessel. In addition, in working condition, the gap between the turns is significant, which can impair hemodynamics, because promotes cavitation, disrupting the laminarity of the blood flow.

The proposed implant device is devoid of these disadvantages.

The implant device for human and animal vessels is made of material with shape memory in the form of a multi-turn body of revolution associated with the delivery device. The multi-turn body of revolution is made of a flat tube having multiple perforations, the ends of which are rigidly connected to form a closed figure of double turns, the end of which are connected by rings, the turns being installed one to the other without a gap, and the size of the body of rotation in working condition corresponds to the size of the affected section of the vessel. The final turns of the multi-turn body of rotation are bent along the longitudinal axis, forming loops for connection with a delivery device made in the form of a flexible catheter with a tip. The tip of the catheter at the distal end has a slot for the loop, and at the proximal end there is a chamfer to safely remove the catheter.

The implant may be characterized in that the multi-turn body of revolution forms a cylinder in working condition, or in that the multi-turn body of rotation forms in operation a two-cone shape with the largest diameter in the middle.

The implant can also be characterized by the fact that the cavity of the flat tube contains a drug with the possibility of its release through perforation, and the fact that the tube is made of a metal alloy of titanium nickelide (NITINOL), and, in addition, the fact that the flat tube is made by crimping a round tubes with a diameter of d = 0.4-3.0 mm.

The technical result is the reduction of injury to the vessel during the introduction and formulation of the proposed implant and reliable provision of a medicinal substance.

The invention is illustrated by drawings, where:

figure 1 shows a closed figure (blank);

figure 2 is a section CC of figure 1;

figure 3 shows a stretched closed figure with loops;

figure 4 is a section bB of figure 3;

figure 5 shows the implant of a reduced diameter in the vessel;

figure 6 shows the placement of bent loops in the vessel;

Fig.7 is a view along arrow B in Fig.5;

on Fig shows the implant in the vessel in working condition;

figure 9 shows the implant in the vessel in the working state of a cylindrical shape;

figure 10 shows the implant in the vessel in the working state of a two-cone shape;

figure 11 shows the implant in a stretched position;

12-13 show an example of the use of the device for varicose veins.

Figure 1-4 shows the process of forming the workpiece. A round tube 1 of a shape memory material, mainly a metal alloy of titanium nickelide (NITINOL), is crimped onto a fixture (not shown) to a flat state, acquiring the shape of an approximately ellipse (Fig. 2). This is done so that in the tube 1 of small diameter (0.4-3.0 mm), holes 2 could be made, thus obtaining multiple perforations for uniform and dosed release of the drug. Then the ends of the obtained flat tube 1 are rigidly connected to the joint, for example, by welding, obtaining a closed figure (figure 1). After that, the closed figure is stretched, forming flattened ellipses 3 (Figs. 3, 4), which are connected by rings 4 (Figs. 3, 4). Then the stretched closed figure 20 is wound on some device, for example, a cylindrical or conical shape, turning it into a multi-turn body of revolution - an implant 5, consisting of twin turns 6, placed without a gap turn to turn. In this case, the final turns 6 of the body of revolution are bent along the longitudinal axis, forming loops 7 and 8 so that then in the vessel 9, loops 7 and 8 lie along the forming vessel 9, without interfering with the blood flow (Fig. 6). The multi-turn body 5 of rotation (implant) may have the shape of a cylinder (Fig. 9) or a two-cone shape with the largest diameter in the middle (Fig. 10). The delivery device is made in the form of a flexible catheter 10 connected to the tip 11 (Fig. 5), on which, on the one hand, a slot 12 is made on its distal end, and on the other hand, a smooth chamfer 13 (Fig. 7). Through the holes 2 of the perforation, the implant 5 is filled with a drug.

Before starting the operation, it is necessary to carry out preparatory work: to determine the size of the clogged or narrowed section 21 of the vessel 9. Then an implant 5 is formed, which consists of double turns 6. The implant 5 is subjected to heat treatment (zevolevat), i.e. ask his material a program to restore shape at a human body temperature of about 37 ° C.

After the program is set, the implant 5 is compressed, making it much smaller in diameter. Then, before the operation, the surgeon selects the implant 5 of the required size until it is reduced, corresponding to the affected area of the vessel. During surgery on a vessel 9 of relatively large diameter with branches, the surgeon stretches the implant of a reduced size (Fig. 11) and inserts a loop 7 of turn 6 into the slot 12 of the tip 11 of the catheter 10. During surgery on a relatively small vessel, the surgeon loops 7 of the implant of a reduced size (Fig. 5 ) immediately inserts 12 tips into the slot. Previously, the surgeon places the drug into the tube 1 of the implant through the holes 2 of the perforation. After that, the surgeon inserts the catheter 10 with the implant 5 into the vessel 9. Then the surgeon, controlling the passage of the catheter 10 with the implant on the monitor screen, conducts the catheter 10 with the implant to the desired location, for example, in the region of the heart. Having reached the narrowed or clogged portion of the vessel 9 and passing it to the desired length, which is controlled on the monitor screen, the surgeon, pulling the catheter 10 towards himself, removes it from the patient’s body, releasing the implant 5. In this case, the chamfer 13 at the proximal end of the tip 11 provides a soft smooth the exit of the catheter 10 with the tip 11 from the vessel 9, without injuring it.

When the implant 5 is heated to a person’s body temperature, it gradually assumes a predetermined shape, expands the walls of the vessel and provides free blood flow (Fig. 8). The placement of loops 7, 8 along the forming vessel 9 does not interfere with hemodynamics. Through holes 2 perforation, the drug will be dosed into the patient's body, preventing thrombosis.

The implementation of the implant 5 biconical, i.e. consisting of two truncated cones 22 with the largest diameter 23 in the middle (figure 10), provides fixation of the implant 5, excluding its movement in the vessel 9, and is intended for use in difficult cases. In simpler cases, the use of an implant in the form of a cylinder is possible (Fig. 9).

It is also possible to use the proposed implant device not only inside the vessel, but also outside. For example, with varicose veins, the implant can be installed directly on the affected vein (vessel 9). An example of such use of this device is shown in Fig. 12. Installed on a vein (vessel 9), an implant 5 in the form of a cuff tightens it, keeping the vessel 9 in a healthy state, preventing the valves 14 from opening (Fig. 13).

Thus, the design of the implant allows you to achieve a technical result - to reduce injury to the vessel during insertion and placement, as well as the reliable flow of the drug into the implant installation area and allows you to use it to restore patency of both relatively large vessels and small and branched vessels.

Claims (5)

1. The implant device for human and animal vessels, made of a material with a shape memory in the form of a multi-turn body of revolution associated with a delivery device, characterized in that the multi-turn body of rotation is made of a flat tube having multiple perforations, the ends of which are rigidly connected to form a closed figure of double turns, the end of which are connected by rings, and the turns are installed one to the other without a gap, and the size of the body of rotation in working condition corresponds to the size of Agen portion of the vessel and has a cylindrical or biconical shape with the largest diameter in the middle, with the final double multiturn windings of rotation of the body are bent along the longitudinal axis to form loops. 2. The delivery device for the implant according to claim 1, characterized in that it is made in the form of a flexible catheter with a tip equipped with a slot for connection with a loop of a loop of a multi-turn body of revolution and a chamfer for safe removal of the catheter. 3. The device according to claim 1, characterized in that the cavity of a flat tube contains a drug substance with the possibility of its release through perforation. 4. The device according to any one of claims 1 and 3, characterized in that the flat tube is made by crimping a round tube with a diameter of d = 0.4-3.0 mm 5. The device of claim 1, characterized in that the tube is made of a metal alloy of titanium nickelide.

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