RU2325122C1 - Implant for blood vessel occlusion - Google Patents

Abstract

FIELD: medicine; medical technique.

SUBSTANCE: implant for blood vessel occlusion contains great number of elongated elements wire or fibre-shaped, first retainer with attached the first ends of elongated elements, the second retainer with attached second ends of the elongated elements and the first covering body, fastened on the elongated elements. In the first condition implant presents an elongated object extended along the longitudinal axis capable of insertion in blood vessel, also capable of transit in the second condition in blood vessel. It is also capable of distance decrease between the holders that causes twisting of the elongated elements according to the axle receiving the great number of radially extended fillets creating at least fixing structure, which increases the transaction of the covering body, and at least one structure which is made with capability of fixation in the second condition. Implant also contains at least one second covering body, fixed on the elongated elements at the distance from the first covering body and made with ability to reduce the distance between the first and the second covering bodies by the decreasing of the distance between the holders. It also has ability to create at least one fixing structure chosen from the group which includes the first fixing structure between the first covering body and the first holder and the second structure between the second covering body and the second holder.

EFFECT: implant for blood vessel occlusion in human body, for example, the gap between atrial septum, or ventricle of heart, and vessel in the body.

14 cl, 7 dwg

Description

FIELD OF TECHNOLOGY

The invention relates to an implant for blocking a blood vessel, more specifically for blocking a blood vessel in a human body, for example, openings through a septum of the atria or ventricle of the heart, or a vessel in the trunk.

BACKGROUND OF THE INVENTION

WO 02/38051 describes a well-functioning implant for blocking a blood vessel. Such an implant has particular use as a cardiological implant, with which you can, for example, block the holes through the septum of the atria or ventricle of the heart. It is made with the possibility of installation and assembly in the right place of the body (for example, in the heart), unlike other previously known implants (for example, the so-called umbrellas and sails), which expand immediately as soon as the compressed umbrella leaves the installation case.

This implant contains many thin, wire-like elongated elements, each of which has proximal and distal ends and is made of a bendable material. The implant further comprises two holders to which the ends of the elongated elements are attached. With a decrease in the distance between the two holders, the elongated elements begin to curl and form many radially directed loops. When the two holders are fixed relative to each other, the loops are fixed in a certain position, due to which the implant is fixed in the vessel.

The implant further comprises an overlapping body fixed to the elongated elements. This overlapping body is placed or expanded when the two holders are joined together and the vessel is closed. In one embodiment, the bladder-like structure expands on both sides of the vessel, such as the atrial septum. In another of the preferred embodiments of the invention, an overlapping body in the form of a disk of elastic material is installed in the middle between two holders, and it is held in an expanded state by twisted elongated elements.

One of the advantages of using an implant with one overlapping body is that only one overlapping body needs to be opened and placed in a vessel. However, sometimes the opening of the vessel is such that the overlapping body is not large enough to reliably close the vessel. Therefore, it is preferable to place the overlapping body on both sides of the partition.

Such an implant is described in US Pat. No. 5,171,259. It contains two patches, each of which consists of an elastic bendable annular base and a piece of fabric stretched onto the base and fixed on it. The patches are installed in such a way that they face each other through the gap and are slightly sewn together around the circumference of the thread from the inside so that when the thread is pulled, the two patches will come closer to each other. Such an implant is inserted into the vessel using a catheter. First, the first patch is released from the catheter and opens, then the catheter is slightly removed before the second patch is released from the catheter and opens. US Pat. No. 4,836,204 describes an implant containing two blisters that also open one after another. These implants have disadvantages in that two overlapping bodies must be placed and opened in the vessel at two different points in time during the surgical operation.

US Pat. No. 6,117,159 describes an implant delivered by a catheter to seal a septal defect, comprising a rod with concentric parallel cutouts passing through the wall of the device, which form flat supports. The center of the supports moves radially from the axis as a hinge in response to the movement of the distal and proximal ends of the device in the direction of the center of the device. Such a device does not contain an overlapping body, but it is coated with determinants that can improve tissue growth.

SUMMARY OF THE INVENTION

The objective of the invention is to provide an improved implant for blocking a blood vessel, more specifically for blocking a blood vessel in the human body.

This problem is solved by creating an implant having the features disclosed in claim 1.

The implant according to the invention contains:

many thin elongated elements, each of which has a first end and a second end;

a first holder to which the first ends of the elongated elements are attached;

a second holder to which the second ends of the elongated elements are attached, wherein the elongated elements are attached to the first and second holders;

a first overlapping body mounted on elongated elements;

moreover, in the first state, the implant is an elongated object, elongated along the longitudinal axis, made with the possibility of inserting into a blood vessel, and also made with the possibility of transition to the second state in the blood vessel and with the possibility of reducing the distance between the holders, causing the elongated elements to twist relative to the specified axis to produce a plurality of substantially radially directed loops forming at least one fixing structure increasing the cross section of the cross tearing the body, and at least one locking structure made with the possibility of fixation in the second state;

moreover, the implant contains at least one second overlapping body, mounted on elongated elements at a distance from the first overlapping body, and is configured to reduce the distance between the first and second overlapping bodies by reducing the distance between the holders and with the possibility of formation of at least one fixing structure, selected from the group comprising a first locking structure between the first overlapping body and the first holder and a second locking structure between the second overlapping their body and the second holder.

Preferably, both locking structures are formed when the holders are joined together. In a preferred embodiment, all elongated implant elements have the same length.

It has been found that such a plugging device containing at least two overlapping bodies can be transferred to the second state in a more easily and controlled manner. The elongated elements are easier to bend to obtain a loop-like twisted locking structure. Therefore, the closure according to the invention does not require much experience and skill to insert and install it in the correct position in the vessel. Even if the lengths of the elongated elements are selected in such a way that the first and second overlapping bodies do not open at the same time and / or the first and second fixing structures do not form at the same time, they nevertheless open or form when the same movements - joining holders together.

Since such an implant contains at least two overlapping bodies that can be installed on two sides of the vessel at the same time, or when performing the same movement, the advantages of the known closure means with two overlapping bodies and the advantages of the known closure means with one overlapping body are combined in the implant according to invention, nor does it have their drawbacks.

These and other advantages and problems solved by the invention will be apparent from the following detailed description of preferred embodiments of the invention with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

1 is a perspective view of an implant according to a first embodiment of the invention in its initial state.

Figure 2 presents the implant according to figure 1 in a partially compressed state.

Figure 3 presents the implant according to figure 1 in a first intermediate state.

Figure 4 presents the implant according to figure 1 in a second intermediate state.

Figure 5 presents the implant according to figure 1 in the third intermediate state.

Figure 6 presents the implant according to figure 1 in the second inserted state.

7 is a perspective view of an implant according to a second embodiment of the invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION

The device according to the invention is based on implants disclosed in WO 02/38051, the description of which is given in this application by reference.

The device according to the invention is made in the form of an implant for blocking an internal blood vessel, for example, an opening in the septum of the atria or ventricle of the heart, or another vessel in the human or animal body that needs to be closed. The implant is compressible for insertion by some delivery mechanism, for example, through a venous vessel and is arranged to open and open to clog the blood vessel after it has been delivered to the position where it is necessary to close the vessel.

Figure 1 shows the implant according to the invention in its original state, i.e. before it was installed in a blood vessel, it was squeezed during its introduction into the vessel and, after its delivery, it was installed in the position where it is necessary to close the vessel.

This implant contains many thin elongated elements 1, such as wires or threads, a first overlapping body 2, at least one second overlapping body 2 ', a first holder 3 and a second holder 4. The implant is elongated along the longitudinal axis A.

The elongated elements 1 are attached by their first, proximal ends to the first holder 3 and second, distal ends to the second holder 4. The proximal end means that this end is closer to the surgeon, and the distal end means that this end is closer to the patient. The elongated members 1 may be attached in a “pre-twisted” or non-twisted state. The elongated elements 1 are usually made of thin rigid material, usually inextensible, but slightly elastic. For example, they can be made from nitinol or other inflexible material. Preferably, they can be made from Phynox (Finox) material, which is a nickel-chromium alloy, or from plastic. Figure 1 shows 8 elongated elements 1. This number is preferred, but it should be understood that the number of elements may be different.

The first and second overlapping bodies 2, 2 'are located between the two holders 3 and 4 and, as a rule, are elongated in the radial direction relative to the longitudinal axis A. Each of them has openings 20, 20'. Elongated elements 1 are attached to the peripheral region of the overlapping bodies 2, 2 '. The overlapping bodies 2, 2' have outer holes 21, 21 'through which the elongated elements pass 1. The elongated elements 1 have thickenings 10 on both sides of the outer holes 21, 21' the overlapping bodies 2, 2 ', which serve to capture and install the overlapping bodies 2, 2', so that the position of the overlapping bodies 2, 2 'between the pairs of two corresponding bulges 10 is fixed in the space between the pairs of bulges 10.

Each of the overlapping bodies 2, 2 'divides each elongated element 1 into three sections. The first section 11 is located between the first holder 3 and the first overlapping body 2, the second section 12 is between the second overlapping body 2 'and the second distal holder 4, and the third section 13 is between the first and second overlapping bodies 2, 2'.

Preferably, at least the first and second sections 11 and 12 of each elongated element 1 are approximately the same length. Preferably, the third sections 13 are of the same length. However, all of them may also have different lengths.

The overlapping bodies 2, 2 'are made of resilient, for example similar to a fabric, material that meets surgical requirements. The preferred material is polyester. They can also be made from biodegradable or bioabsorbable material. Preferably, the overlapping bodies 2, 2 ′ are made of the same material and have the same dimensions. However, various types of the first and second overlapping bodies 2, 2 ′ can also be used.

The overlapping bodies 2, 2 ′ must have a distal surface 22 directed towards the second holder 4 and a proximal surface 23 directed towards the first holder 3. They have at least approximately a disk shape, preferably a circle shape, at least in their unfolded state, preferably also in their original state. Since they are made of elastic material, they can be brought into a compressed form, for example, similarly to an umbrella.

For insertion of the implant into the vessel, a carrier rod 5 and a motive means 6, such as a catheter or other suitable tube, can be used. The implant can be administered intravenously. However, it can also be administered through the esophagus or other suitable channels of the body. The carrier rod 5 slides through the first holder and the central holes 20, 20 ′ in the first and second overlapping bodies 2, 2 ′ and is held in a fixed but movable state in the second holder 4. FIG. 2 shows an implant mounted on the carrier rod 5 and partially compressed by means of the nozzle 60 of the driving means 6. Compression of the implant causes a decrease in the external cross-section or diameter of the overlapping bodies 2, 2 '.

The implant is inserted into the vessel in the first fully compressed state. When it is placed in the desired place, the pipe 60 is removed. Further, to push the first holder 3 towards the second holder 4, a push rod 61 is used and / or the carrier rod 5 is pushed out, as a result of which the second holder 4 moves closer to the first holder 3, which in this case is held in place. Due to the fact that the first and second holders are approaching each other, the elongated elements 1 are bent and, ultimately, twisted with the formation of fixing structures. At the same time, the overlapping bodies 2, 2 'are installed and take on their original disk shape.

Figure 3-5 shows the various intermediate states of the implant during its movement.

The convergence of the holders 3 and 4 first leads to the fact that the first and second sections 11 and 12 of inextensible elongated elements 1 take a softly curved outward configuration relative to the longitudinal axis A. The third sections 13 are also bent. Further movement of the holder 3 in the direction of the second holder 4 leads to the fact that the first and second sections 11 and 12 of the elongated elements 1 take a more curved, almost semicircular configuration. At the same stage, inextensible elongated elements 1 pass through a critical point, and the first and second sections 11 and 12 “snap” with the formation of radially directed loops, which leads to a somewhat concave structure of each of the sections in the form of a petal. This means that the first and second sections 11 and 12 are eventually twisted, and each section 11 and 12 forms, together with the same section of another elongated element 1, a first and a second fixing structure, respectively. These fixing structures are shaped like a flower or a wind turbine. The third sections 13 are bent to a lesser extent than the first and second sections 11 and 12.

Preferably, the first and second sections 11 and 12 are twisted in the same way, and the first and second locking structures obtained from them have the same outer diameter. The third sections 13 are usually bent like a spring, but do not twist like the first and second sections 11 and 12. The third sections 13 form in this second state a bent structure with an external diameter that is preferably the same size as the cross-sectional diameter of two overlapping bodies 2 , 2 '. If the overlapping bodies have different sizes, the bent structure may have the same diameter as one of the overlapping bodies 2, 2 ', and this diameter may be equal to the diameter of a larger or smaller overlapping body or have an intermediate value.

Figure 6 presents the implant in its final and second state. In this state, the implant is placed in a vessel, the fixing structures are formed and the overlapping bodies 2, 2 'are installed. Overlapping bodies 2, 2 'are strengthened and form a body that blocks the flow of fluid from both sides of the partition. The shape of the overlapping bodies 2, 2 'can be the same as in the initial state, or it can be expanded. The position of the overlapping bodies in the vessel is fixed with the help of fixing structures formed by twisted and fixed elongated elements 1.

One way to keep the implant in this second state, i.e. to fix the elongated elements 1 in their twisted state, is to attach the holders 3 and 4 to each other. In this embodiment, the holders 3 and 4 comprise a locking mechanism, preferably consisting of elements 30 and 40 that snap together, which block the elongated elements 1 in a twisted state. These blocking means are already described in WO 02/38051, therefore, their description is not repeated here.

7 shows another preferred embodiment of the invention. The implant according to this embodiment comprises a body 7 made of a compressible material, such as a cotton swab. The body 7 is located between two overlapping bodies 2, 2 'and holds inside the third sections 13 of the elongated elements 1. Such a compressible material allows you to clog the vessel.

The implant according to the invention combines the advantages of an implant with one overlapping body with the advantages of an implant with two overlapping bodies.

The list of positions in the drawings:

one elongated elements 10 thickening eleven first section 12 second section 13 third section 2 first overlapping body 2 ' second overlapping body twenty central holes twenty' central holes 21 outer holes 21 ' outer holes 22 distal surface 23 proximal surface 3 first holder thirty first snap element four second holder 40 second snap element 5 carrier rod 6 propulsion 60 branch pipe 61 push rod 7 compressible body but longitudinal axis

Claims (14)

1. An implant for clogging a blood vessel, containing: many elongated elements (1) in the form of a wire or thread, each of which has a first end and a second end; a first holder (3) to which the first ends of the elongated elements (1) are attached; a second holder (4) to which the second ends of the elongated elements (1) are attached, wherein the elongated elements (1) are attached to the first holder (3) and the second holder (4); the first overlapping body (2), mounted on elongated elements (1); moreover, in the first state, the implant is an elongated object, elongated along the longitudinal axis (A), made with the possibility of inserting into a blood vessel in this first state, and also made with the possibility of transition to the second state in the blood vessel and with the possibility of reducing the distance between the holders ( 3, 4), causing the elongated elements (1) to twist about the axis (A) to produce a plurality of essentially radially directed loops forming at least one fixing structure that increases the cross section of the overlapping body (2), and at least one locking structure, made with the possibility of fixing in the second state, characterized in that it contains at least one second overlapping body (2 '), mounted on elongated elements (1) at a distance from the first overlapping body (2), and is configured to reduce the distance between the first overlapping body (2) and the second overlapping body (2 ') by reducing the distance between the holders (3, 4), and with the possibility of forming at least one phi a casing structure selected from the group comprising a first fixing structure between the first overlapping body (2) and the first holder (3), and a second fixing structure between the second overlapping body (2 ') and the second holder (4). 2. The implant according to claim 1, where the first locking structure and at least one second locking structure are formed in the second state. 3. The implant according to claim 1, characterized in that it contains only one second overlapping body (2 '), the elongated elements (1) include the first sections (11) located between the first holder (3) and the first overlapping body (2), the second sections (12) located between the second holder (4) and the second overlapping body (2 '), and the third sections (13) located between the first overlapping body (2) and the second overlapping body (2'). 4. The implant according to claim 3, where the first sections (11) and second sections (12) of each elongated element (1) are approximately the same length. 5. The implant according to claim 3, where the first sections (11), second sections (12) and third sections (13) of each elongated element (1) have approximately the same length. 6. The implant according to claim 3, where the third sections (13) are not twisted, like the first sections (11) and the second sections (12). 7. The implant according to claim 3, where in the second state, the first fixing structure is formed by the first sections (11), and the second fixing structure is formed by the second sections (12). 8. The implant according to claim 3, where in the second state the bent structure is formed by the third sections (13) and has approximately the same external diameter as the diameter of the cross section of at least one of the overlapping bodies (2 and 2 '). 9. The implant according to claim 1, where in the second state, the first overlapping body (2) and at least one second overlapping body (2 ') have cross sections of the same size. 10. The implant according to claim 1, where the first overlapping body (2) and at least one second overlapping body (2 ') are made of elastic material and each of them has a substantially disk shape in the second state, and in the first state is compressed form. 11. The implant according to claim 10, where the first overlapping body (2) and at least one second overlapping body (2 ') have at least approximately the shape of a circle. 12. The implant according to claim 1, where the first overlapping body (2) and at least one second overlapping body (2 ') have holes (21, 21') through which elongated elements (1) pass. 13. The implant according to claim 1, where all the elongated elements (1) have the same length. 14. The implant according to claim 1, where the compressible body (7) is between the first overlapping body (2) and at least one second overlapping body (2 ').

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