KR20210152870A - Vascular hemostasis tool - Google Patents

Abstract

The present invention relates to a vascular hemostasis tool, and more specifically, to a vascular hemostasis tool, which can be inserted into a perforated site of a vascular to close the perforation and suppress bleeding. The present invention includes: an external fixing member including a first elastic wrinkle portion; and a vascular insertion member which is connected to the first elastic wrinkle portion and includes a second elastic wrinkle portion, is coupled to the external fixing member and inserted into the perforation.

Description

Vascular hemostatic device {VASCULAR HEMOSTASIS TOOL}

The present invention relates to a vascular hemostatic device, and more particularly, to a vascular hemostatic device inserted into a perforated site of a blood vessel to close the perforation and suppress bleeding.

As cardiovascular diseases increase, the frequency of medical procedures such as interventional medical procedures and angiography is increasing. These stent procedures are divided into vascular and non-vascular, and vascular stents are divided into coronary stents, peripheral stents, and cerebrovascular stents.

Here, for coronary artery stent or angiography, a catheter in the form of a long and thin tube is used, and this catheter is inserted into the perforated passage between the skin tissue and the blood vessel so that various medical procedures can be easily performed through the blood vessel from the outside. .

At this time, since a coronary stent or angiography is performed on a coronary artery with high blood pressure, a perforation occurs at the insertion site after the procedure.

In such a perforation, excessive blood is discharged due to high blood pressure, and since it is difficult to stop hemostasis by itself, the perforation site of the blood vessel is closed until the blood vessel is regenerated, or the surrounding tissue is pressed to stop hemostasis.

Manual compression is a procedure that compresses the surrounding tissue. If the patient's movement is limited for more than 6 to 12 hours after the procedure, and the operator's hand or compression tool is used to press the perforated area with irregular pressure for a long time, It may cause medical side effects such as arrhythmic thrombosis, embolism, and hematoma, and there is a problem in that the procedure time and success rate vary depending on the situation.

As a hemostasis method that compensates for the above-mentioned problems with the manual pressure killer, there is a perforated blood vessel occlusion method in which hemostasis is stopped by directly blocking the inside of a perforated site of a blood vessel.

A perforated blood vessel occlusion device is used to directly block the perforated site of the blood vessel using a biodegradable polymer material in the procedure of the perforated blood vessel occlusion method.

Briefly describing the structure of the conventional perforated blood vessel closure device, an anchor-type insertion member made of a biodegradable polymer material is located at the end of a tube having a long and thin inner passage, and a pulling thread is connected to one side of the insertion member to the inside of the tube through to the opposite end. After the insertion member is inserted into the perforation site, if it is caught on the inner wall surface of the blood vessel at a point inside the blood vessel, a hemostatic sponge is inserted through the inside of the tube using a separate pushing member, thereby blocking the passage through the insertion member and the sponge. bleeding proceeds.

However, since the conventional perforated blood vessel closure device has a structure that supports the hemostatic sponge in a state in which the insertion member is pulled by the pulling thread, the posture of the insertion member must be adjusted so that the anchor-shaped insertion member is caught on the inner wall surface of the blood vessel, There is a problem that requires high skill of the operator, such as to distribute an appropriate force so that the pulling thread is not excessively pulled.

In addition, if a part of the insertion member is cut or a part of the connection section of the pulling thread is cut due to excessive pressure during the procedure, the insertion member or the hemostatic sponge may flow into the blood vessel as it is, which may cause a fatal medical accident.

Republic of Korea Patent Registration No. 10-0695758 (Registered on March 09, 2007)

The present invention has been devised to solve the above problems, and the present invention is to provide a vascular hemostatic device capable of hemostasis by easily blocking vascular perforation with a simplified structure without requiring high skill of the operator, unlike the prior art. .

In addition, an object of the present invention is to provide a vascular hemostatic device in which the insertion member has a structure in which the insertion member is inserted into the perforation by itself, and the risk of breakage is small and the risk of loss into the blood vessel is minimized.

In order to solve the above problems, the present invention provides an external fixing member including a first elastic wrinkle part and a blood vessel connected to the first elastic wrinkle part and including a second elastic wrinkle part and coupled to the external fixing member to be inserted into the perforation It may include an insert member.

In addition, the vascular insert may be formed of nanofibers including collagen, PLGA, and deca (TECA), and the vascular insert may contain 1 wt% to 3 wt% of deca (TECA).

In addition, the blood vessel insertion member may include a cylindrical porous nanofiber support whose pore size increases as the distance from the central axis of the perforation increases.

In addition, the blood vessel insertion member may include a coagulation promoting unit coupled to the external fixing member and a coagulation inhibiting unit coupled to the coagulation promoting unit.

In addition, the present invention may further include a first telescopic fixing member coupled to the outside of the external fixing member.

In addition, the present invention may further include a second telescoping fixing member including a through-pin coupled through the external fixing member and a telescopic adjustment nut coupled to the through-pin.

The present invention can easily prevent vascular perforation with a simplified structure, thereby simplifying vascular hemostasis. In addition, the present invention can reduce the risk of being lost to the inside of the blood vessel because the blood vessel insertion member is coupled to the external fixing member and is inserted into the perforation by itself, and there is little risk of breakage.

The vascular hemostatic device according to an embodiment of the present invention may be expanded in the vascular perforation by a component including collagen and nanofibers including TECA, thereby preventing bleeding.

1 is a perspective view of a vascular hemostatic device according to an embodiment of the present invention.
2 is a diagram schematically illustrating a state of use of a vascular hemostatic device according to an embodiment of the present invention.
3 and 4 are diagrams for explaining the detailed structure of a vascular hemostatic device according to an embodiment of the present invention.
FIG. 5 is a view showing a cross-section taken along line AA′ of FIG. 1 , and is a view showing a cross-section of the blood vessel insertion member according to the present embodiment.
6 is an image showing the results of testing the concentration and diameter of the nanofibers suitable for the vascular hemostatic device of the present invention, Deca (TECA).
7 is a diagram schematically illustrating a vascular hemostatic device according to an embodiment of the present invention.
8 is a view schematically showing that the vascular hemostatic device according to the second embodiment of the present invention is inserted into the perforation.
9 is a view schematically showing that the vascular hemostatic device according to the second embodiment of the present invention is inserted into the perforation and fixed.
10 is a view showing that the vascular hemostatic device according to the third embodiment of the present invention is reduced by being inserted into the perforation.
11 is a view showing the expansion of the vascular hemostatic device according to the third embodiment of the present invention is inserted into the perforation.

Advantages and features of the present invention, and a method for achieving them will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but will be implemented in various different forms.

Hereinafter, the technical features of the present invention will be described in detail with reference to the accompanying drawings.

1 is a perspective view of a vascular hemostatic device according to an embodiment of the present invention. 2 is a diagram schematically illustrating a state of use of a vascular hemostatic device according to an embodiment of the present invention.

The configuration and function of the vascular hemostatic device 100 according to the present embodiment will be described with reference to FIGS. 1 and 2 .

The vascular hemostatic device 100 according to the present embodiment is inserted into the perforation P to stop the perforation site, and may include an external fixing member 10 and a blood vessel insertion member 20 .

The external fixing member 10 may be attached to the surface of the skin in which the blood vessels are perforated, and may block the perforation of the blood vessels (P).

Here, the external fixing member 10 may include a first elastic wrinkle portion (10a).

The first elastic wrinkle portion 10a may be compressed by a pressing action applied from the outside to the inside of the external fixing member 10 or expanded by a pulling action applied from the inside to the outside.

In this way, the external fixing member 10 may be expanded or contracted in the outer diameter direction from the central axis C of the perforation P by the first elastic wrinkle portion 10a.

Here, the external fixing member 10 may have a disk shape having a predetermined thickness. However, the external fixing member 10 is not limited to a circular shape, and may be formed in a prismatic shape.

In addition, the external fixing member 10 may be made of nanofibers containing components such as regeneration promoter, antibiotic, anti-inflammatory agent, TECA, etc. can have In this case, the external fixing member 10 may include an adhesive layer having adhesiveness so that one side contacting the skin is attached to the skin surface.

The blood vessel insertion member 20 may be formed of a material that is absorbed into the body, such as a bioabsorbable surgical material, and may be coupled to the external fixing member 10 and inserted into the perforation.

Here, the blood vessel insertion member 20 may include a second elastic wrinkle portion 20a connected to the first elastic wrinkle portion 10a of the external fixing member 10 .

The second elastic wrinkle portion 20a may be connected to the first elastic wrinkle portion 10a to be operated in connection with the operation of the first elastic wrinkle portion 10a.

In this way, the blood vessel insertion member 20 may be expanded or contracted in the outer radial direction from the central axis C of the perforation P by the second elastic wrinkle portion 20a.

3 and 4 are diagrams for explaining the detailed structure of a vascular hemostatic device according to an embodiment of the present invention.

3 and 4, the vascular hemostatic device 100 is inserted into the perforation (P). At this time, the external fixing member 10 is attached and fixed to the surface of the skin (S) to cover the periphery of the perforation (P), the blood vessel insertion member 20 is inserted into the perforation (P) to block the passage.

Here, when an external force is applied to the external fixing member 10 , the first elastic wrinkle portion 10a may be contracted or expanded in the outer diameter direction of the central axis C by the external force. In addition, the second elastic wrinkle portion 20a may be stretched and contracted by the stretching action of the first elastic wrinkle portion 10a.

In this way, the blood vessel insertion member 20 may be expanded or contracted in the outer diameter direction of the central axis C of the perforation P by the second elastic wrinkle portion 20a. That is, since the size of the diameter of the blood vessel insertion member 20 can be expanded or reduced, it can be adjusted to correspond to the size of the perforation.

Therefore, the present invention can provide a simplified vascular hemostatic device that can easily prevent vascular perforation even if the skill of the operator is not high.

In addition, since the present invention blocks the vascular perforation by being directly inserted into the perforation passage while blocking the peripheral portion of the perforation, the hemostatic effect can be improved by double sealing the passage and the hole while suppressing blood elution.

And, since it can be adjusted to correspond to the size of the perforation, it is possible to increase the hemostatic action by blocking the passage.

In addition, according to the present invention, since the blood vessel insertion member 20 is inserted into the perforation while being fixed to the skin through the external fixing member 10, problems such as the inflow of the blood vessel insertion member into the blood vessel due to breakage can be prevented in advance. have.

5 is a view showing a cross-section in the width direction of the blood vessel insertion member according to the present embodiment. 6 is an image showing the results of testing the concentration and diameter of the nanofibers suitable for the vascular hemostatic device of the present invention, Deca (TECA).

The vascular insertion member 20 may be made of nanofibers including collagen, PLGA, and TECA. Specifically, the nanofibers constituting the blood vessel insertion member 20 include 1 wt% to 3 wt% of TECA, and the diameter of the nanofibers may be 2.15 μm to 3.22 μm.

Referring to FIG. 5 , the vascular insert 20 may include a cylindrical porous nanofiber support 21 whose pore size increases as the distance from the central axis C of the perforation P increases.

Here, the porous nanofiber support 21 may have different pore sizes depending on the diameter of the nanofibers or the density of the nanofibers. For example, the blood vessel insertion member 20 can form a small diameter size of nanofibers organized at the inner center and increase the density to form a smaller pore size, and form a larger diameter size as it moves away from the inner center, By lowering the density, it is possible to form a large pore size.

Referring to FIG. 6 , as the content of deca (TECA) increases, the diameter of the nanofiber is reduced, and when the content of deca (TECA) is 5 wt% or more, it can be seen that the nanofiber is not formed well. Therefore, it can be seen that nanofibers suitable for vascular hemostatic devices are most suitable when the content of TECA is 1wt% to 3wt%, and the most suitable when the diameter is 2.15㎛ to 3.22㎛.

Accordingly, in the present invention, collagen and TECA components of the vascular insertion member 20 inserted into the perforation can be expanded by reaction with body fluid, thereby preventing bleeding by compression hemostasis.

And, since the blood vessel insertion member 20 contains a TECA component, the blood vessel regeneration function is excellent, and it is possible to more effectively stop blood vessels.

In addition, since the blood vessel insertion member 20 absorbs blood through the pores of the porous nanofiber support 21, the blood reaction can be further improved by increasing the area in which the absorbed blood comes into contact with the nanofiber, and the inner Because pores of the size are formed, a dense blood response can be induced.

Here, in the perforation site into which the blood vessel insertion member 20 is inserted, after the blood vessels are stopped, the skin cells are regenerated over time and the skin tissue moves toward the central axis of the perforation. The porous nanofiber support inserted into the perforation passage ( 21), skin cells can be adsorbed to the pore surface during regeneration of skin cells.

As a result, in the blood vessel insertion member 20 according to this embodiment, the pore size of the porous nanofiber support 21 decreases from the outside to the inside center. As the skin tissue proliferates and moves toward the inner center, which is small in size, the outer surface is fixed to the perforation passage and can stably serve as a support.

7 is a diagram schematically illustrating a vascular hemostatic device according to an embodiment of the present invention.

Referring to FIG. 7 , the blood vessel insertion member 20 may include a coagulation promoting unit 20b coupled to the external fixing member 10 and a coagulation inhibiting unit 20c coupled to the coagulation promoting unit 20b.

The coagulation promoter 20b may include a coagulation promoter component that promotes blood coagulation, for example, a coagulation promoter composed of any one or a combination of a plurality of hemostatic drug components such as thrombin, calcium, and vitamin K. .

The coagulation inhibitor 20c may include an anticoagulant component that inhibits blood coagulation, for example, any one or a combination of a plurality of anticoagulant drug components such as heparin, nadroparin, bemiparin, dalteparin, and enoxaparin. It may include a coagulation inhibitor consisting of.

Here, the blood vessel insertion member 20 is a coagulation accelerator mixed with the nanofibers containing the above-described Deca (TECA) component at the position of the coagulation promoting unit 20b, and coagulating with the nanofibers at the position of the coagulation inhibitor 20c. The inhibitor may be mixed, and alternatively, the coagulation accelerator and the coagulation inhibitor may be formed as separate coating layers on the surface.

Accordingly, the blood vessel insertion member 20 causes the blood to rapidly coagulate at a position adjacent to the surface of the skin S due to the action of the coagulation promoter included in the coagulation promoting unit 20b together with the deca (TECA) component so that the blood is transferred to the outside. elution can be inhibited.

In addition, the blood vessel insertion member 20 temporarily inhibits the blood clotting action by the coagulation inhibitor 20c, thereby preventing a thrombus from occurring in a position adjacent to the blood vessel wall W. At this time, after the efficacy of the coagulation inhibitor is exhausted, the hemostatic action may be performed by a blood reaction even at the position of the coagulation inhibitor 20c due to the TECA component of the vascular insertion member 20 .

Meanwhile, FIGS. 8 and 9 are diagrams schematically illustrating a vascular hemostatic device according to a second embodiment of the present invention. 8 is a view schematically showing that the vascular hemostatic device according to the second embodiment of the present invention is inserted into the perforation. 9 is a view schematically showing that the vascular hemostatic device according to the second embodiment of the present invention is inserted into the perforation and fixed.

8 and 9 , the vascular hemostatic device 200 according to the second embodiment of the present invention may include an external fixing member 210 , a blood vessel insertion member 220 , and a first elastic fixing member 230 . can

Here, the external fixing member 210 and the blood vessel insertion member 220 according to the second embodiment of the present invention have the same configuration as the external fixing member 10 and the blood vessel insertion member 20 according to the first embodiment of the present invention. And, since it is the same component, a detailed description thereof will be omitted below.

The first telescopic fixing member 230 may be coupled to the outside of the external fixing member 210 . Specifically, the first elastic fixing member 230 may be formed of a member having a predetermined elasticity, such as rubber or silicone, and may include an adhesive layer having adhesiveness so as to be attached to the skin surface on one side thereof.

At this time, it is preferable that the first elastic fixing member 230 is composed of at least one pair of members and coupled to both sides of the external fixing member 210 , and the operator holds the pair of first elastic fixing members 230 to both sides. The stretching operation of the wrinkle part can be induced by the pulling and pushing operation.

Accordingly, in the vascular hemostatic device 200 according to the second embodiment of the present invention, each wrinkle portion of the external fixing member 210 and the blood vessel insertion member 220 is compressed and expanded using the first elastic fixing member 230 . Stretching operation can be easily performed.

In addition, since the first elastic fixing member 230 is attached and fixed to the skin surface, it is possible to stably fix the vascular hemostatic device 200 together with the external fixing member 210 to the skin.

10 and 11 are diagrams schematically illustrating a vascular hemostatic device according to a third embodiment of the present invention. 10 is a view showing that the vascular hemostatic device according to the third embodiment of the present invention is reduced by being inserted into the perforation. 11 is a view showing the expansion of the vascular hemostatic device according to the third embodiment of the present invention is inserted into the perforation.

10 and 11 , the vascular hemostatic device 300 according to the third embodiment of the present invention may include an external fixing member 310 , a blood vessel insertion member 320 , and a second elastic fixing member 330 . can

Here, the external fixing member 310 and the blood vessel insertion member 320 according to the third embodiment of the present invention have the same configuration as the external fixing member 10 and the blood vessel insertion member 20 according to the first embodiment of the present invention. And, since it is the same component, a detailed description thereof will be omitted below.

The second telescoping fixing member 330 may include a through-pin 331 that is through-coupled to the external fixing member 310 , and an expansion-controlling nut 332 coupled to the through-pin 331 .

At this time, the through pin 331 and the expansion and contraction control nut 332 may be screw-coupled, and the expansion and contraction control nut 332 is coupled to one end of the through pin 331 and rotates as it rotates, one side of the external fixing member 310 . It can move in the direction of pressing or move in the opposite direction.

In this way, the second elastic fixing member 330 compresses the wrinkle portion by pressing the external fixing member 310 from the outside to the inside by a rotation operation as shown in FIG. 10, or in the opposite direction as shown in FIG. It can be moved to release the compression state.

Accordingly, the vascular hemostatic device 300 according to the third embodiment of the present invention can conveniently perform a stretching operation in which each wrinkle portion is compressed and expanded by using the second elastic fixing member 330 .

In addition, according to the vascular hemostatic device 300 according to the third embodiment of the present invention, the second expansion and contraction fixing member 230 can adjust the amount of expansion and contraction of the wrinkle portion by adjusting the rotation amount of the expansion and contraction adjustment nut 332 , so that the blood vessel insertion member The diameter size of 320 can be precisely adjusted to correspond to the size of the perforation (P) and the adjustment state can be fixed, and the vascular perforation can be compressed and sealed, thereby enhancing the effect of vascular hemostasis.

The above description is merely illustrative of the technical idea of the present invention, and various modifications and variations will be possible without departing from the essential characteristics of the present invention by those of ordinary skill in the art to which the present invention pertains. Accordingly, the embodiments disclosed in the present invention are for explanation rather than limiting the technical spirit of the present invention, and the scope of the technical spirit of the present invention is not limited by these embodiments.

Therefore, the protection scope of the present invention should be interpreted by the following claims rather than being limited by the above-described embodiments, and all technical ideas within an equivalent range should be interpreted as being included in the scope of the present invention.

100, 200, 300: vascular hemostatic device
10, 210, 310: external fixing member 20, 220, 320: blood vessel insertion member
230: first elastic fixing member 330: second elastic fixing member

Claims (6)

an external fixing member including a first elastic wrinkle part; and
and a blood vessel insertion member connected to the first elastic wrinkle portion, including a second elastic wrinkle portion, and coupled to the external fixing member to be inserted into the perforation. The method of claim 1,
The vascular insert is formed of nanofibers containing collagen, PLGA, and TECA,
The vascular insertion member is a vascular hemostatic device comprising 1 wt% to 3 wt% of Deca (TECA). The method of claim 1,
The blood vessel insertion member,
Vascular hemostatic device comprising a cylindrical porous nanofiber support, the pore size increases as the distance from the central axis of the perforation. The method of claim 1,
The blood vessel insertion member,
A blood vessel hemostatic device comprising a coagulation promoting unit coupled to the external fixing member and a coagulation inhibiting unit coupled to the coagulation promoting unit. The method of claim 1,
Vascular hemostatic device further comprising a first telescopic fixing member coupled to the outside of the external fixing member. The method of claim 1,
A vascular hemostatic device further comprising a second telescoping fixing member including a through-pin coupled to the external fixing member through-connected to the through-pin and an expansion/contraction nut coupled to the through-pin.

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