KR102546790B1 - Expandable medical sheath - Google Patents

Abstract

The present invention relates to an expandable medical sheath capable of easily hemostasis a blood vessel by radially expanding a region including an extension of a first tube, thereby increasing a hemostasis area on the surface of a blood vessel.

Description

Expandable medical sheath}

The present invention relates to an expandable medical sheath.

In general, an introducer sheath provides a safe passage from the outside of the skin to the inside of a blood vessel to help entry of other devices. Mainly, it is applied to femoral artery, brachial artery, radial artery, etc., and may also be applied to coronary artery, carotid artery, aorta, etc.

When the medical sheath has a passage to the inside of a patient's blood vessel, other devices can be inserted into the hollow of the sheath for diagnosis and treatment. More specifically, the medical sheath includes a sheath (tube) having a long and thin inner passage and an anchor made of an inflatable balloon or a biodegradable polymer material positioned at a front end (end) of the sheath. In addition, a thread for pulling is connected to the inflatable balloon or anchor, and the thread for pulling has a structure extending to the opposite end through the inside of the sheath.

Here, the anchor of the inflatable balloon or biodegradable polymer material becomes a state in which it is possible to switch to a posture parallel to or orthogonal to the sheath at the front end of the sheath while being supported by the thread for pulling. In addition, a collagen sponge for hemostasis is inserted into the sheath to block the puncture site of blood vessels, and a pushing member is positioned above the hemostasis sponge.

In the medical sheath of this structure, an inflatable balloon or an anchor of a biodegradable polymer material is inserted into the perforated portion of the blood vessel in a position parallel to the tube at the tip of the sheath, and then converted to a position where it can be caught on the inner wall surface of the blood vessel at a point inside the blood vessel. do. Thereafter, the hemostasis sponge is pushed outward from the passage of the perforated blood vessel to the point where it is caught on the anchor side by using the pushing member, and is positioned. That is, hemostasis proceeds by blocking the inner region of the perforated blood vessel by the balloon or anchor and blocking the outer region of the perforated blood vessel by the hemostatic sponge.

However, in the conventional medical sheath, even if a sheath suitable for blood vessel examination is selected, there is the inconvenience of changing to a sheath suitable for inserting a hemostatic tool, and since a small hemostatic sponge must be selected according to the inner diameter of the sheath, blood vessel During hemostasis, there was a problem in that the hemostasis sponge got into the blood vessel. In addition, since the hemostatic area is limited due to the use of a small-sized hemostatic sponge, there is a problem in that the hemostatic effect is poor.

The present invention is intended to solve the above-mentioned problems, by increasing the hemostatic area at the perforation site of the blood vessel, improving the adhesive ability of the hemostatic agent on the surface of the blood vessel, and also improving the hemostatic ability, so that the blood vessel perforation site can be easily hemostasis. However, it is intended to provide an expandable medical sheath that can solve the problem of the hemostatic sponge entering the inside of the blood vessel.

In order to achieve the above object, an expandable medical sheath is provided. In one example, an expandable medical sheath according to the present invention includes a first tube extending in the longitudinal direction and having a hollow therein, including an extension part branched into a plurality by a cutout extending from one end; And a second tube having a structure surrounding at least one surface of the inner circumferential surface and the outer circumferential surface of the first tube. At this time, the first and second tubes have a structure in which the region including the extension of the first tube radially expands.

In another example, the expandable medical sheath has a structure in which a second tube is adhered, mounted, or coated on at least one of an inner circumferential surface and an outer circumferential surface of the first tube.

In another example, the expandable medical sheath has a structure in which a second tube is adhered, mounted, or coated on an outer circumferential surface of the first tube.

In addition, the expandable medical sheath according to the present invention has a structure in which the outer diameter gradually decreases from the other end to one end or a structure in which the outer diameter gradually decreases from the other end to a predetermined portion of one end.

In a specific example, the first tube of the expandable medical sheath according to the present invention includes n (n is an integer of 2 or more) cutout grooves and extensions extending from one end. In addition, each extension has a structure formed so as to taper toward one end from the other end.

In addition, the first tube is made of polyetheretherketone (PEEK), polystyrene (PS), polyethylene (PE, polyethylene) and polypropylene (PP, polypropylene), polyimide (PI, polyimide), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene terephthalate (PET, Polyethylene terephthalate), and nylon (Nylon). can Furthermore, the second tube is made of silicone, nitrile rubber, polyetheretherketone (PEEK), polystyrene (PS), polyethylene (PE, polyethylene) and polypropylene (PP, polyimide). (PI, Polyimide), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene terephthalate (PET, Polyethylene terephthalate) and nylon (Nylon) It may include one or more selected from.

In one example, the expandable medical sheath according to the present invention is characterized by satisfying the following condition 1:

[Condition 1]

E1 > E2

In condition 1, E1 represents the elastic modulus of the first tube, and E2 represents the elastic modulus of the second tube. At this time, in condition 1, E1 may be in the range of 0.4 to 4 GPa, and E2 may be in the range of 0.01 to 0.4 GPa.

In another example, the expandable medical sheath according to the present invention is characterized in that the expandable medical sheath satisfies the following condition 2:

[Condition 2]

H1 > H2

In condition 1, H1 represents the hardness of the first tube, and E2 represents the hardness of the second tube.

In the expandable medical sheath according to the present invention, the region including the extension of the first tube is radially expanded, so that the area of hemostasis at the perforation site of the blood vessel can be increased. Accordingly, there is an advantage in that the adhesive ability of the hemostatic agent on the blood vessel surface and the hemostasis ability are also improved, thereby easily hemostasis at the puncture site of the blood vessel.

1 is a schematic diagram of an expandable medical sheath according to one embodiment of the present invention.
2 is a schematic diagram of a first tube of an expandable medical sheath according to one embodiment of the present invention.
3 is a cross-sectional view of one end of an expandable medical sheath according to one embodiment of the present invention ((a) before expansion, (b) after expansion).
4 is a schematic diagram of a first expandable medical tube according to another embodiment of the present invention.
5 is a schematic diagram of a blood vessel hemostasis device including an expandable medical sheath according to one embodiment of the present invention.
6A to 6J are views illustrating a process of hemostasis of a blood vessel using an expandable medical sheath according to an embodiment of the present invention.

The present invention relates to an expandable medical sheath capable of easily hemostasis blood vessels by increasing the hemostasis area on the surface of blood vessels.

More specifically, the present invention, in one example,

A first tube extending in the longitudinal direction and having a hollow formed therein, including an extension portion branched into a plurality by a cutout extending from one end; and

Including a second tube having a structure surrounding at least one surface of the inner circumferential surface and the outer circumferential surface of the first tube,

The first and second tubes provide an expandable medical sheath characterized in that they have a structure in which a region including an extension of the first tube radially expands.

Among the terms used in the present invention, "one side" means the side adjacent to the target site in use, and means the side adjacent to the target site in the device. “End” refers to a portion of the device, ie, one end, which end of the device is brought into proximity with the target site.

In addition, "the other side" means the side opposite to the target site in use, and means the side opposite to the target site in the device. "Other end" means one end opposite to the one end opposite to the target site.

In addition, the term "target site" refers to a body part where hemostasis is desired, and may refer to a perforated blood vessel. In the present specification, "target site" will be used interchangeably with "vascular perforation". can

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. Prior to this, the terms or words used in this specification and claims should not be construed as being limited to the usual or dictionary meaning, and the inventor appropriately uses the concept of the term in order to explain his/her invention in the best way. It should be interpreted as a meaning and concept consistent with the technical idea of the present invention based on the principle that it can be defined.

Therefore, since the embodiments described in this specification and the configurations shown in the drawings are only one of the most preferred embodiments of the present invention and do not represent all of the technical ideas of the present invention, various alternatives may be used at the time of this application. It should be understood that there may be equivalents and variations.

1 is a schematic diagram of an expandable medical sheath according to one embodiment of the present invention, FIG. 2 is a schematic diagram of a first pipe of the expandable medical sheath according to one embodiment of the present invention, and FIG. 3 is one embodiment of the present invention Cross-sectional view of one end of the expandable medical sheath ((a) before expansion, (b) after expansion), Figure 4 is a schematic diagram of a first expandable medical tube according to another embodiment of the present invention, Figure 5 is the present invention 6A to 6J are diagrams of a blood vessel hemostasis device including an expandable medical sheath according to an embodiment of the present invention, and FIGS.

Hereinafter, with reference to FIGS. 1 to 6J , an expandable medical sheath and a vascular hemostatic device including the expandable medical sheath of the present invention will be described in detail.

The expandable medical sheath according to the present invention is characterized in that a hollow is formed therein, and one end region is radially expandable by insertion of a medical instrument. More specifically, in the expandable medical sheath according to the present invention, a region including the extension of the first tube may be radially expanded.

Accordingly, there is an advantage in that the blood vessel can be easily hemostasis by increasing the hemostasis area on the surface of the blood vessel.

Expandable Medical Sheath

As shown in FIG. 1, the expandable medical sheath 100 according to the present invention includes a first tube 110 and a second tube 120.

In one example, the expandable medical sheath 100 according to the present invention extends in the longitudinal direction so that a hollow is formed therein, and the extension part 112 branched into a plurality by the cutout groove 111 extending from one end It is configured to include a first tube 110 including a first tube 110 and a second tube 120 having a structure surrounding at least one of the inner and outer circumferential surfaces of the first tube 110. At this time, the second tube 120 has a structure in which the area including the extension 112 of the first tube 110 radially expands.

In a specific example, the expandable medical sheath 100 according to the present invention has a structure in which the second tube 120 surrounds at least one surface of the inner circumferential surface and the outer circumferential surface of the first tube 110, the first tube 110 and the second tube 110. The tube 120 has a structure forming one tube with a hollow inside. In particular, by inserting a medical instrument or the like into the hollow of the expandable medical sheath 100, the extension portion 112 of the first tube 110 is radially expanded, and thus the second tube 120 extends to the extension portion. A region where 112 is located may be radially expanded. That is, an end region of one side of the expandable medical sheath 100 may be radially expanded. A detailed operating mechanism will be described later.

In one example, the expandable medical sheath 100 according to the present invention may have a structure in which an outer diameter gradually decreases from the other end to one end. More specifically, one side of the expandable medical sheath 100 is a part that goes deep into the body, such as inside a blood vessel. desirable. Meanwhile, the outer diameter of the expandable medical sheath 100 may have a structure in which the outer diameter gradually decreases from the other end to one end, or may have a structure in which the outer diameter gradually decreases from the other end to a predetermined portion of one end. Here, the predetermined portion may mean a region corresponding to a range of 0.02 to 0.8 of the total length from one end of the expandable medical sheath 100 .

In addition, as described above, in the expandable medical sheath 100 according to the present invention, one end region of the expandable medical sheath 100 can be expanded by inserting a medical instrument, and when it is maximally expanded, the expandable medical sheath ( 100) The outer diameter of one side may have a size corresponding to that of the other side. Accordingly, since the inner diameter can be increased when a wider working space is required during the procedure, there is an advantage in that additional devices do not need to be changed.

In one example, the expandable medical sheath 100 according to the present invention includes a first tube 110 and a second tube 120.

As shown in FIG. 2, the first tube 110 is a tube constituting the frame of the expandable medical sheath 100, and a hollow is formed therein. It includes a branched extension (112). The first tube 110 may be a polymer having rigidity, and may maintain the overall length and shape of the expandable medical sheath 100 .

In a specific example, the first tube 110 may include an extension part 112 branched into a plurality by a cutout groove 111 extending from one end. More specifically, the first tube 110 includes n (n is an integer of 2 or more) number of cutout grooves 111 and extensions 112 extending from one end. Here, n may be an integer ranging from 2 to 10. In the drawing, the cutout groove 111 and the extension portion 112 include four, but are not limited thereto.

Meanwhile, the cutout groove 111 may be a structure for dispersing force applied to a material when the expandable medical sheath 100 is radially expanded. In addition, each extension part 112 may have a structure formed so as to be tapered from the other end to one end. Each extension part 112 is formed to be tapered, and the outer diameter may gradually decrease from the other side of the first tube 110 to one side.

The first tube 110 maintains the overall length and shape of the expandable medical sheath 100 and may be made of a rigid polymer material. In a specific example, the first tube 110 is composed of polyetheretherketone (PEEK), polystyrene (PS), polyethylene (PE, polyethylene) and polypropylene (PP), polyimide (PI, Polyimide), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene terephthalate (PET, Polyethylene terephthalate) and nylon (Nylon) may contain one or more. For example, the first pipe 110 may be polyetheretherketone (PEEK).

In one example, the second tube 120 has a structure surrounding at least one surface of the inner circumferential surface and the outer circumferential surface of the first tube 110. In particular, the second pipe 120 may be made of a deformable material and has elasticity. Accordingly, the second tube 120 can be easily expanded radially. In a specific example, the second tube 120 is made of silicone, nitrile rubber, polyetheretherketone (PEEK), polystyrene (PS), polyethylene (PE), and polypropylene (PP). ), polyimide (PI, Polyimide), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) and nylon (Nylon ) may include one or more selected from the group consisting of. For example, the second tube 120 may be made of silicone or nitrile rubber, or may be made of silicone. In this case, the diameter of the second tube 120 made of silicon may be radially expanded by other means. On the other hand, the first pipe 110 and the second pipe 120 may be made of the same material or different materials, and in the case of the same material, the physical properties of the first pipe 110 and the second pipe 120 can be different. For example, the first tube 110 and the second tube 120 may have different elastic modulus or hardness, and the first tube 110 may have a higher elastic modulus and hardness than the second tube 120. . A detailed description will be given later.

As described above, in the first tube 110 of the expandable medical sheath 100 according to the present invention, the area of the extension part 112 is radially expanded, and the second tube 120 is the first tube 110 The area including the extension portion 112 of has a structure that extends radially. On the other hand, as shown in Figure 3, the first pipe 110 is not a structure in which the length (C) of the arc of the skeleton of the extension portion 112 is extended, but the distance (D) of the extension portions 112 adjacent to each other As this becomes farther away, the diameter of the first tube 110 is expanded. That is, the arc length of each extension 112 of the first tube 110 is maintained constant, but the distance between the extensions 112 at one end of the expandable medical sheath 100 is increased. At this time, the diameter of one side of the second tube 120 made of a deformable material is radially expanded. Meanwhile, the first tube 110 as well as the second tube 120 may also be made of a deformable material. However, since the physical properties of the first tube 110 and the second tube 120 are different, the first tube 110 can be radially expanded due to the distance D of the extension parts 112 adjacent to each other, , The diameter of the second tube 120 itself may be expanded radially.

That is, the expandable medical sheath 100 according to the present invention includes the first tube 110 and the second tube 120 having different physical properties, and can maintain the overall length and shape of the expandable medical sheath 100, , the diameter of one end of the expandable medical sheath 100 can be easily expanded radially.

More specifically, the expandable medical sheath 100 may satisfy the following condition 1:

[Condition 1]

E1 > E2

In condition 1, E1 represents the elastic modulus of the first tube 110, and E2 represents the elastic modulus of the second tube 120. At this time, in condition 1, E1 may be in the range of 0.4 to 4 GPa, and E2 may be in the range of 0.01 to 0.4 GPa.

Furthermore, the expandable medical sheath 100 may satisfy condition 2 below.

[Condition 2]

H1 > H2

In condition 2, H1 represents the hardness of the first pipe 110, and H2 represents the hardness of the second pipe 120. At this time, in condition 2, H1 may be 50A or more, and H2 may be less than 50A.

In another example, the expandable medical sheath 100 according to the present invention has a structure in which the second tube 120 is adhered, mounted, or coated on at least one of the inner and outer circumferential surfaces of the first tube 110 . That is, the first tube 110 may adhere to the second tube 120 to form one body. In this case, when the expandable medical sheath 100 is inflated, the region of the second tube 120 to which the first tube 110 is adhered may not expand. In addition, the first tube 110 and the second tube 120 may have a structure in which a hole 113 is formed in the extension part 112 of the first tube 110 to help each other adhere when bonding or coating. (See Fig. 4).

In another example, the expandable medical sheath 100 according to the present invention has a structure in which the second tube 120 is adhered or coated on the outer circumferential surface of the first tube 110 .

Furthermore, although the first and second tubes 110 and 120 are in contact with each other, they may not be attached to each other. In a specific example, in this case, a hole 113 may be formed in the extension part 112 of the first tube 110 to prevent the second tube 120 from being pushed down from the first tube 110. In the hole 113 of the first pipe 110, the surface of the second pipe may be fastened or adhered. At this time, when the first tube 110 is expanded, all parts of the second tube 120 may be expanded. Therefore, it can be more stable because the tension is evenly distributed compared to the case where the first pipe 110 and the second pipe 120 are adhered to each other.

As described above, the expandable medical sheath 100 according to the present invention is characterized in that one end of the expandable medical sheath 100 is radially expandable by insertion of a medical instrument. This medical sheath 100 can be used in all procedures in which a general medical introducer sheath is used. For example, it can be used in all procedures using medical guide tubes, such as perforated blood vessel occlusion, angioplasty, and heart valve angioplasty.

blood vessel hemostasis device

5 is a schematic diagram of a blood vessel hemostasis device including an expandable medical sheath according to one embodiment of the present invention. As shown in FIG. 5 , in one example of the present invention, a blood vessel hemostasis device including an expandable medical sheath is provided.

In one example, the blood vessel hemostasis device according to the present invention includes an expandable medical sheath 100, a balloon 200, a guide member 300, a sponge 400 for hemostasis, and a pushing member 500.

In a specific example, the vascular hemostatic device according to the present invention is capable of sliding movement in the hollow of the expandable medical sheath 100 and the expandable medical sheath 100, the guide member 300 having a hollow therein, and the guide member 300 It includes a sponge 400 for hemostasis located in the hollow, and a pushing member 500 located in the hollow of the guide member 300 and pressing the sponge 400 for hemostasis.

In particular, one end of the expandable medical sheath 100 is expanded by the advancement of the guide member 300 . More specifically, in the expandable medical sheath 100, the area where the extension of the first tube is formed may radially expand. Since descriptions of each component of the expandable medical sheath 100 have been described above, they will be omitted.

Furthermore, the vascular hemostatic device including the expandable medical sheath 100 can radially expand one end of the expandable medical sheath 100, thereby increasing the hemostatic area on the surface of the blood vessel perforation. A hemostatic sponge (eg, sealant) can solve the problem of falling into the perforation of the blood vessel.

In addition, the blood vessel hemostasis device may further include an anchor made of an inflatable balloon 200 or a biodegradable polymer material at one end. More specifically, an inflatable balloon (or anchor) is positioned at the tip (end) of the medical sheath 100 . In addition, a thread for pulling is connected to the inflatable balloon (or anchor), and the thread for pulling has a structure extending to the opposite end through the inside of the sheath.

vascular hemostasis process

6A to 6J are views illustrating a process of hemostasis of a blood vessel using an expandable medical sheath according to an embodiment of the present invention. Referring to FIGS. 6A to 6J , a blood vessel hemostasis process using the expandable medical sheath according to the present invention will be described in detail.

First, the expandable medical sheath 100 is advanced to the target site. In a specific example, one end of the expandable medical sheath 100 is inserted into the inner wall of the blood vessel 1, which is a perforation site, and the balloon 200 (or anchor) is inserted into the blood vessel 1 through the hollow inside the expandable medical sheath 100. It is inserted into the inner wall, and the balloon 200 located on the inner wall of the blood vessel 1 is inflated (Fig. 6a-b).

The medical sheath 100 inserted into the perforation of the blood vessel 1 is positioned on the outer wall of the blood vessel 1, and the inflated balloon 200 is directed toward the blood vessel 1 so that it is caught on the perforation of the inner wall of the blood vessel 1. pull (Fig. 6c)

Then, after the guide member 300 is inserted into the hollow of the medical sheath 100, the sponge 400 for hemostasis is inserted into the guide member 300. Then, the pushing member 500 is positioned on the upper surface of the hemostasis sponge 400 (FIG. 6d).

Next, the guide member 300 is advanced to one side of the expandable medical sheath 100 . At this time, the diameter of the medical sheath 100 is radially expanded by the guide member 300 . Meanwhile, by the advancement of the guide member 300, the extension of the first tube of the medical sheath for expansion is radially expanded, and accordingly, the second tube may also be radially expanded. That is, the guide member 300 expands the diameter of the medical sheath 100 and advances the hemostatic sponge 400 to one end of the medical sheath 100 . When the sponge 400 for hemostasis is applied to the wall of the blood vessel 1, the sponge 400 for hemostasis is pressed against the outer wall of the blood vessel 1 using the pushing member 500 (FIG. 6e-g).

Then, after shrinking the balloon 200 placed on the inner wall of the blood vessel 1, it is removed from the medical sheath 100. After that, the expandable medical sheath 100 and the guide member 300 are removed from the target area, and then the pushing member 500 is also removed. At this time, only the sponge 400 for hemostasis remains, so that the puncture site of the blood vessel 1 can be hemostasis (FIG. 6h-j).

The expandable medical sheath 100 according to the present invention has an advantage in that the area including the extension of the first tube is radially expanded, thereby increasing the hemostasis area on the surface of the blood vessel, thereby easily hemostasis the blood vessel.

1: blood vessels
100: expandable medical sheath
110: tube 1
111: notched groove
112: extension
113: adhesion part
120: second pipe
200: balloon
300: guide member
400: Sponge for hemostasis
500: pushing member

Claims (11)

A first tube extending in the longitudinal direction and having a hollow formed therein, including an extension portion branched into a plurality by a cutout extending from one end; and
Including a second tube having a structure surrounding at least one surface of the inner circumferential surface and the outer circumferential surface of the first tube,
The first and second tubes have a structure in which a region including an extension of the first tube extends radially,
A plurality of holes are formed in the extension of the first pipe so that the surface of the second pipe can be fastened with the extension of the first pipe, so that the first pipe and the second pipe are in contact but not attached to each other. , When the extension of the first tube expands radially, all parts of the second tube expand,
It is a structure that gradually decreases from the other end to a predetermined portion of one end,
Each extension has a structure formed so as to taper from the other end to one end,
The outer diameter of one side corresponds to the outer diameter of the other side when the end area of one side is maximally expanded,
The expandable medical sheath satisfies the following condition 1:
[Condition 1]
E1 > E2
In condition 1, E1 represents the elastic modulus of the first tube, E2 represents the elastic modulus of the second tube,
In condition 1 above, E1 is in the range of 0.4 to 4 GPa, E2 is in the range of 0.01 to 0.4 GPa,
The expandable medical sheath satisfies the following condition 2:
[Condition 2]
H1 > H2
In condition 2, H1 represents the hardness of the first tube, and E2 represents the hardness of the second tube. According to claim 1,
The expandable medical sheath has a structure in which a second tube is adhered, mounted, or coated on at least one of an inner circumferential surface and an outer circumferential surface of the first tube.
According to claim 1,
The expandable medical sheath is an expandable medical sheath having a structure in which a second tube is adhered, mounted, or coated on an outer circumferential surface of a first tube.
delete delete According to claim 1,
The expandable medical sheath characterized in that the first tube includes n (n is an integer of 2 or more) cutout grooves and extensions extending from one end. According to claim 1,
Tube 1 is composed of polyetheretherketone (PEEK), polystyrene (PS), polyethylene (PE) and polypropylene (PP), polyimide (PI), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene terephthalate (PET, Polyethylene terephthalate) and nylon (Nylon). expandable medical sheath.
According to claim 1,
The second tube is made of silicone, nitrile rubber, polyetheretherketone (PEEK), polystyrene (PS, polystyrene), polyethylene (PE, polyethylene) and polypropylene (PP, polypropylene), polyimide (PI, Polyimide), polyurethane (PU, Polyurethane), polycarbonate (PC, Polycarbonate), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene terephthalate (PET, Polyethylene terephthalate) and nylon (Nylon) An expandable medical sheath comprising one or more.
delete delete delete

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