WO2019135427A1

WO2019135427A1 - Inferior vena cava filter and procedure kit for installing inferior vena cava filter, comprising same

Info

Publication number: WO2019135427A1
Application number: PCT/KR2018/000223
Authority: WO
Inventors: 김동기; 박종하
Original assignee: 인제대학교 산학협력단
Priority date: 2018-01-05
Filing date: 2018-01-05
Publication date: 2019-07-11

Abstract

A procedure kit for installing an inferior vena cava filter is disclosed. To this end, the present invention comprises: an inferior vena cava filter filtering out blood clots moving along the corresponding blood vessel while inserted and held in a blood vessel; and a catheter, which is a related tool used in the holding of the inferior vena cava filter in a predetermined location in a blood vessel after being held in the blood vessel while accommodating the inferior vena cava filter therein, or in the removal thereafter of the inferior vena cava filter, wherein the inferior vena cava filter comprises: a blood clot capturing part formed in the shape of a spiral cone by making one strand of steel wire into a three-dimensional shape, so as to capture, when held in a blood vessel, blood clots moving along the corresponding blood vessel; and a tool joining head part integrally formed on an upper end tip of the blood clot capturing part such that a related tool used for installing the inferior vena cava can be connected therewith and operated.

Description

Inferior vein filter and inferior vein filter with it

The present invention relates to an inferior vein filter and an operation kit for an inferior vena cava filter including the same. More particularly, the present invention relates to an inferior vena cava filter for filtering blood clots in an inferior vena cava And an inferior vein filter equipped with the same.

Venous thromboembolism is a disease that involves deep vein thrombosis and pulmonary thromboembolism. It has a high morbidity rate of 422 people per 100,000 population in 2006 in the United States. ) And mortality.

In particular, hospitalized patients are at increased risk due to limited movement and unstable hemodynamic status compared to healthy individuals.

In patients with venous thromboembolic complaints, they usually complain of edema and pain or chest pain in the lower extremities but may be found incidentally without symptoms.

Anticoagulants are the most preferred method to prevent venous thromboembolism and bleeding, which is a complication of anticoagulants, is reported to be less than 5%.

However, the prevalence of pulmonary embolism is still high after appropriate anticoagulant treatment, and the use of inferior vena cava filter (IVC filter) for prevention or treatment with anticoagulant therapy is continuously increasing.

On the other hand, the indications for the establishment of the inferior vena cava filter to prevent pulmonary embolism are largely divided into absolute, relative and preventive purposes.

Absolute indications are cases of absolute contraindications to the use of anticoagulants such as intracerebral hemorrhage or active intestinal bleeding, failure of anticoagulant therapy, and serious complications of anticoagulant therapy.

Relative indications are those in which the extent of thrombosis is greater or greater, anticoagulant therapy alone is more likely to cause pulmonary embolism, patients with impaired cardiopulmonary function, and pulmonary embolism frequently recur.

In addition, if the patient does not have deep vein thrombosis or pulmonary embolism, the above-mentioned inferior vein filter should be installed for the purpose of preventing trauma, major surgery, or limited long-term movement.

However, most of the inferior vein filters generally used up to now are formed into a conical shape of an umbrella fusiform structure by using a plurality of iron wires, and each of the iron wires can be folded or unfolded before or during a procedure.

However, the sharp end of the wire may damage blood vessels, causing complications such as hemorrhage, and adhering to blood vessels in a state of being stuck in the inner wall of the blood vessel, thereby making it impossible to remove the subsequent filter.

It is an object of the present invention to solve the above-mentioned problems, and it is an object of the present invention to provide a thrombus capturing part having a spiral conical shape by the implementation of a three-dimensional shape using one strand of wire, The present invention provides an inferior vena cava filter capable of minimizing vascular adhesion during insertion.

It is another object of the present invention to increase the flexibility of intravascular insertion by reducing the volume of the thrombus capturing part through shape deformation so as to enable shape deformation and circular restoration of the thrombus capture part by adopting a shape memory alloy material.

In addition, the present invention provides an inferior vein filter that minimizes damage to blood vessels during and after a procedure and at the same time facilitates removal of the filter in the future.

It is still another object of the present invention to provide a catheter that is a device that is indispensable in inserting and introducing the inferior vein filter into a vein (inferior vein), wherein a marker is attached to the tip of the catheter, An inferior vena cava filter for facilitating the determination of the position of the catheter for position determination, and an operation kit for an operation for installing an inferior vein filter including the same.

According to an aspect of the present invention, there is provided an under-vein filter for filtering blood clots flowing along a blood vessel while being inserted into a blood vessel. And a catheter which is an associated device for use in introducing the inferior vena cava filter into a predetermined position in a blood vessel after being inserted into a blood vessel in a state in which the inferior vena cava filter is internally accommodated or for removing the inferior vein filter in the future The lower vein filter includes a thrombus capture part for collecting a thrombus flowing along the blood vessel when the blood vessel is introduced into the blood vessel by forming a spiral conical shape through the implementation of a three-dimensional shape using one strand of wire, And a mechanism binding head unit formed integrally with the lower vein filter to enable connection operation of an associated instrument used in the installation of the lower vein filter.

In addition, the catheter is a tubular body having a predetermined length, and a marker for determining the position when the inferior vein filter is inserted into the blood vessel and adhered to the defined position is further provided Respectively.

In addition, the inferior vein filter extends from the mechanism binding head and has a ring shape having a predetermined diameter through the implementation of a three-dimensional shape using a single strand of wire. Thus, , And a filter balance holding portion for restricting the instrument binding head to be positioned at the center of the blood vessel without being biased in any one direction by abutting against the inner wall surface of the blood vessel.

The lower end of the thrombus capture part is bent inward to prevent the distal end from digging the inner wall of the blood vessel when it comes into contact with the inner wall of the blood vessel.

In addition, a first adhesion inhibiting tube for minimizing blood vessel adhesion in the case of abutting against the inner wall of the blood vessel is coated on the lower side of the thrombus capture part, respectively.

The wire is made of Nitinol, which is a shape memory alloy.

In addition, at the end of the filter balance maintaining portion, a second inward end is bent inward to prevent the distal end from digging into the blood vessel when it comes into contact with the inner wall of the blood vessel.

In addition, a second adhesion inhibiting tube for minimizing blood vessel adhesion in the case of abutting against the inner wall of the blood vessel is coated on the entire region of the filter balance maintaining portion.

As can be seen from the above description, the operation of the inferior vein filter of the present invention and the inferior vein filter installing operation kit including the same according to the present invention, as the thrombus capturing part for filtering out the thrombus takes the form of a helical cone, In addition to prevention of vascular injury, it is possible to suppress the vascular adhesion as much as possible, so that the effect of the inferior vena cava filter installation can be enhanced and the inhibitory effect of the onset of complications can be lowered.

In addition, since the shape deformation and the shape restoration of the thrombus capturing part made of Nitinol (Ni-Ti), which is a shape memory alloy, are possible, the filter accommodation into the catheter through volume reduction, It is possible to achieve both convenience of operation and stability of the operation such as repositioning of the filter position and removal of the filter in the future.

At the same time, it is possible to greatly improve the probability of success in the installation of the lower limb vein filter for the temporary prevention of venous thromboembolism by attaining various effects as described above. Thus, along with the development of related medical technology, It is a very useful invention that can greatly contribute to the establishment and improvement of technical development based on this.

1 is a perspective view showing a configuration of an inferior vein filter according to the present invention;

2 is a cross-sectional view showing a configuration of a catheter according to the present invention;

FIGS. 3A to 3F are diagrams illustrating steps in a process of installing an inferior vein filter according to the present invention.

4 is a perspective view showing another embodiment of an inferior vein filter according to the present invention.

FIG. 2 is a cross-sectional view showing a constitutional relationship of a catheter according to the present invention, and FIGS. 3A to 3F are cross-sectional views illustrating an inferior vein filter according to the present invention, FIG. 8 is an exemplary view showing a stepwise process of installation.

As shown in FIGS. 1 and 2, an inferior vein filter according to the present invention and an operation kit for an inferior vein filter installation operation including the same include an inferior vein filter inserted and retracted into the inferior vein, which is a main vein of the venous system, (1), which is inserted into the blood vessel in a state in which the inferior vein filter (1) is internally accommodated, and then placed in a predetermined position in the blood vessel, And a catheter 2 which is an additional surgical tool used to introduce the inferior vein filter 1 or to remove the inferior vein filter 1 in the future.

The IVC filter 1 is a means for filtering blood clots flowing along the inferior vein (hereinafter, referred to as "blood vessel"). The IVC filter 1 forms a spiral conical shape through the implementation of a three- A thrombus capturing part 11 for collecting a thrombus flowing along the blood vessel when the blood vessel is caught in the blood vessel capturing part 11 and a related device used for installing an inferior vein filter, And a mechanism binding head unit 12 that allows connection operation of the operation unit (additional operation tool).

Here, the material of the wire for realizing the shape of the thrombus capture part 11 can be easily deformed by an external force when a geometric shape is formed, but can be restored to its original shape when an external force is lost Nitinol, which is a shape memory alloy, is used as its material.

A first inwardly bent end 111 is formed at the lower end of the thrombus capture unit 11 so that the tip of the lowermost spiral having a maximum diameter does not penetrate the inner wall of the blood vessel.

In addition, a hooking groove 121 is formed in the instrument coupling head 12 so that a separate snare, which is one of the related mechanisms used in the installation of the inferior vein filter, is attached to remove the filter adhered to the inside of the blood vessel. The circumferential surface is formed on one side.

Correspondence of the male thread formed at the tip of the connecting wire, which is one of the related devices used for the insertion of the inferior vein filter necessary for inserting the filter into the blood vessel, re-adjusting the position of the blood vessel, or removing the filter already taken in the blood vessel. And a female screw hole 122 for fastening is formed inwardly at the upper end.

In addition, a first adhesion suppressing tube 112 for preventing vascular adhesion to the utmost is provided at a lower end of the blood thrombus capture unit 11, which is in contact with the inner wall surface of the blood vessel when the filter is inserted into the blood vessel, ).

Here, the first adhesion suppressing tube 112 is flexible enough to cope with the deformation of the thrombus capture portion 11.

It is preferable that the material is harmless to the human body such as silicone which is widely known as the material of the alternative implant. In addition, it may be provided in various forms such as a tube or a film, and its configuration may be omitted according to a procedure condition.

A catheter (2) is an additional treatment tool necessary for installing an inferior vein filter using the inferior vein filter (1).

Is a pipe having a length that allows the inferior vena cava filter (1) to be pulled in both directions so as to be deformed into a shape similar to a linear shape, and to be capable of sufficiently receiving the interior even if it is elongated.

In addition, a marker 21 for position identification is provided at the distal end in the direction in which the lower vein filter 1 advances.

This is for the purpose of position determination and position selection when the inferior vein filter 1 is inserted into a blood vessel and the blood vessel is adhered to a defined position.

4 is a perspective view illustrating another embodiment of an inferior vein filter according to the present invention.

It is possible to keep the blood vessels and the filters in a state in which the blood vessels and the filters maintain a straight line when the filter is introduced into the blood vessels by differentiating the structure of the lower vein vein filter 1.

To this end, as shown in FIG. 4, a ring (not shown) extending from the mechanism binding head 12 and having a predetermined diameter through the implementation of a three-dimensional shape using a single strand of wire similar to the thrombus capture portion 11 ring.

And a filter balance holding portion (13) for preventing the mechanism binding head portion (12) from being biased in any one direction while abutting against the inner wall surface of the blood vessel when the filter is held in the blood vessel.

The material of the wire for realizing the shape of the filter balance holding part 13 can be easily deformed by an external force when the geometric shape is formed like the thrombus capture part 11 described above But it is preferable to use nitinol which is a shape memory alloy exhibiting a property of being restored to its original shape when an external force is lost.

Similarly to the first inwardly directed tip 111, an end of the inwardly bent second inwardly bent tip end portion of the filter balance maintaining portion 13 is bent inwardly in order to prevent the tip end of the inwardly bent blood vessel wall from colliding with the inner wall of the blood vessel. (131) is formed.

In addition, the second adhesion inhibiting tube 132 may be coated on the entire region of the filter balance maintaining portion 13 that is in contact with the inner wall surface of the blood vessel when the filter is inserted into the blood vessel.

(T) is the thrombus that flows along the inferior vein, and (810) and (820) are the additional vessels used in the preparation of the inferior vein filter And the lasso.

The operation of the inferior vein filter according to the present invention constructed as described above and the operation kit for the inferior vein filter installation operation including the same will be described in detail as follows.

First, in order to temporarily prevent pulmonary embolism, an inferior vein filter 1 of the present invention is inserted into a blood vessel (b, an inferior vein) to filter blood clots. There are many related organizations that are needed.

That is, in order to insert the inferior vein filter 1 into the blood vessel, a connecting wire 810 is used as an associated mechanism together with the catheter 2, and then the inferior vein filter 1 is removed from the blood vessel In addition to the connection wire 810, the snare 820 is further used as an associated mechanism.

Thereafter, the inferior vein filter 1 according to the present invention is inserted into and retracted into the blood vessel using the above-mentioned related mechanism.

3A, the thrombus capturing portion 11 of the inferior vein filter 1 is pulled to deform the shape so as to have a shape similar to a linear shape so that the inferior vein filter 1 is inserted into the catheter 2, A male screw thread formed on the distal end of the connecting wire 810 is fastened to the female screw hole 122 of the mechanism fastening head 12 before the fastening head 12 And the connecting wire 810 are integrated with each other, the inferior vein filter 1 can be easily inserted into the blood vessel using the connecting wire 810.

Then, as shown in FIG. 3B, the catheter 2 in which the inferior vein filter 1 is housed is inserted into the blood vessel b and is held at a predetermined position. As shown in FIG. 3C, It is possible to retreat the catheter 2 in a state of being firmly fixed to the connecting wire 810.

At this time, whether or not the inferior vein filter 1 has reached the predetermined position can be easily grasped together with confirmation of the insertion position of the catheter 2 by determining the position of the marker 21 provided at the distal end of the catheter 2.

Subsequently, when the catheter 2 is withdrawn so that the inferior vein filter 1 is withdrawn from the catheter 2, the thrombus capture part 11, as shown in FIG. 3D, So that the thrombus t flowing along the blood vessel b can be filtered out.

Finally, when the insertion of the inferior vein filter 1 is completed at a predetermined position in the blood vessel b as described above, as shown in FIG. 3E, the connecting wire 810 is inserted into the mechanism binding head 1, (12), it is possible to finish the installation of the inferior vena cava filter.

In contrast, when the temporary prevention of pulmonary embolism through the inferior vein filter installation is completed, the inferior vein filter 1 held in the blood vessel b is removed. As shown in FIG. 3F, And the connecting wire 810 is formed integrally with the tool binding head 12 and the connecting wire 810 in a state where the connecting wire 810 is firmly fixed to the female screw hole 122 of the apparatus binding head 12, The catheter 2 is inserted again into the blood vessel b so that the inferior vein filter 1 is internally accommodated.

Thereafter, the snare 820 is hooked on the hooking groove 121 formed on a part of the circumferential surface of the instrument binding head portion 12, and then the lower vein vein filter 1 (1) separated from the blood vessel b by the catheter 2 Can be easily taken out and removed by using the snare 820.

To summarize, an inferior vein filter according to the present invention and an inferior vein filter insertion operation kit for inserting the inferior vein filter 1 for filtering a blood clot flowing along a vein, The effect of facilitating the operation of the filter installation technique can be obtained, and the process of removing and removing from the inside of the blood vessel can be facilitated.

In addition, it is possible to minimize the vascular injury and vascular adhesion during the operation of installing the inferior vein filter as described above, thereby maximizing the success probability and the therapeutic effect of the inferior vein filter installation, It is possible to prevent the occurrence of complications such as hemorrhage due to vascular injury to the utmost.

Claims

An inferior vein filter for filtering thrombus flowing along the blood vessel while being inserted into the blood vessel; And

And a catheter, which is an associated device used for introducing the inferior vein filter into a predetermined position in the blood vessel after insertion into the blood vessel, or for removing the inferior vein filter in the state where the inferior vein filter is internally accommodated,

The lower vein filter includes a thrombus capturing part for collecting a thrombus flowing along the blood vessel when the blood vessel is introduced into a spiral conical shape through the implementation of a three-dimensional shape using one strand of wire, And a mechanism binding head which is integrally formed to allow a connection operation of a related apparatus used for installing an inferior vena cava filter.
The method according to claim 1,

The catheter is a tubular body having a predetermined length,

Further comprising a marker for determining a position when the inferior vein filter is inserted into the blood vessel and the blood vessel is adhered to a defined position, at a distal end in the direction in which the inferior vein filter is advanced.
The method according to claim 1,

The lower vein filter has a ring shape having a predetermined diameter through the implementation of a three-dimensional shape extending from the mechanism binding head portion and using a single strand of wire,

Further comprising a filter balance retaining portion that rests on the inner wall surface of the blood vessel so as to be positioned at the center of the blood vessel without being biased in any one direction by being abutted against the inner wall surface of the blood vessel when the insertion of the inferior vein filter is performed. Intravenous filter installation.
The method according to claim 1,

Wherein a first inward tip is bent inward to prevent the distal end from digging the inner wall of the blood vessel when the inner wall of the blood vessel catching portion comes into contact with the inner wall of the blood vessel.
The method according to claim 1,

And a first adhesion inhibiting tube for minimizing blood vessel adhesion when the blood vessel is in contact with an inner wall of the blood vessel is coated on a lower side of the thrombus capture unit.
4. The method according to any one of claims 1 to 3,

Wherein the wire is made of Nitinol, which is a shape memory alloy.
The method of claim 3,

Wherein a second inward end of the filter balance maintaining portion is bent inward to prevent the tip of the filter balance holder from digging into the blood vessel when it comes into contact with the inner wall of the blood vessel.
The method of claim 3,

And a second adhesion inhibiting tube for minimizing blood vessel adhesion when the blood vessel is in contact with the inner wall of the blood vessel is coated on the entire region of the filter balance maintaining portion.