Embolism protection device

Abstract

The invention discloses an embolism protection device, and belongs to the technical field of interventional therapy instruments. The filter is arranged on the periphery of the long and thin supporting main body in a sleeving manner and has an unfolded structure which is outwards unfolded relative to the radial direction of the long and thin supporting main body; the far end of the filter is a closed end, and the near end of the filter is an open end; when the filter is in the unfolded configuration, an opening for thrombus to enter the filter is formed in the open end, and a seal for holding the thrombus is formed in the closed end; the tying rope is tied to the open end of the filter, and at least one end of the tying rope extends to the operation end; the tether is used for driving the open end to gather so as to reduce the size of the opening. The tying rope is tied at the open end of the filter, when the filter and thrombus in the filter need to be withdrawn from the body, the tying rope is pulled to the near end through the operation end, the tying rope drives the open end to gather together, and the opening of the open end is shrunk or completely closed, so that the thrombus is wrapped in the filter; and the thrombus escape risk in the process of withdrawing the embolism protection device is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to an embolic protection device. Background Art

[0002] When atherosclerotic stenosis occurs in peripheral blood vessels, coronary arteries, and carotid arteries, balloon angioplasty or stent implantation is usually used clinically to restore the normal lumen and blood flow of the blood vessels. However, in this process, the plaques at the stenotic site are subject to the external force of the balloon or stent, and may break or fall off. Once these broken plaques drift with the blood to the distal blood vessels, especially into the cerebral blood vessels, they may cause embolism and lead to ischemic stroke, which seriously threatens the life, health, and safety of the patient.

[0003] To this end, people have invented an embolic protection device. Without affecting blood perfusion, a filter is opened at the distal end of the diseased segment of the blood vessel to intercept and collect plaques that fall off during the operation. After the operation is completed, the embolic protection device together with the thrombus intercepted in the embolic protection device is removed from the human body. The use of the embolic protection device effectively reduces the risk of embolism in distal blood vessels and improves the success rate of the operation.

[0004] Conventional distal protection is to determine the diameter of the blood vessel through medical methods such as angiography or OCT, and select an embolic protection device with a corresponding outer diameter. Existing embolic protection devices generally use a deployable filter to intercept thrombi. After the filter is deployed, the proximal end is open, and the thrombi enter the filter from the proximal opening. The distal end of the filter is closed to hold the thrombi and prevent them from escaping. However, when the open filter is withdrawn from the body, there is still a risk of thrombi escaping. Summary of the invention

[0005] In view of this, the present invention provides an embolic protection device to solve the defect that the thrombus may escape outward from the filter opening during the withdrawal of the existing embolic protection device from the body, thereby providing an embolic protection device.

[0006] In order to solve the above technical problems, the technical solution of the present invention is as follows: An embolic protection device, comprising: A slender support body; A filter is sleeved on the outer periphery of the slender support body, and the filter has an expanded configuration that expands radially outward relative to the slender support body; the distal end of the filter is a closed end, and the proximal end of the filter is an open end; when the filter is in the expanded configuration, the open end forms an opening for the thrombus to enter the filter, and the closed end forms a seal that holds the thrombus; A tether is tied to the open end of the filter, and at least one end of the tether extends to the operating end; the tether is used to drive the open end to gather under the control of the operating end to reduce or close the opening.

[0007] Furthermore, when the filter is in the expanded configuration and the operating end does not pull the tether proximally, the tether provides support for the open end of the filter to keep the open end in an open state; when the filter is in the expanded configuration and the operating end pulls the tether proximally, the tether drives the open end to gather to shrink or close the opening.

[0008] Furthermore, the tether is a memory alloy wire having a shape memory function, or the tether is a memory alloy developing wire having both a shape memory function and a developing function.

[0009] Furthermore, the open end of the filter is provided with a plurality of rope threading holes arranged along its circumference, and the tether includes a tie section arranged circumferentially around the open end, and the tie section is passed through the plurality of rope threading holes; at least one end of the tie section is connected to a traction section extending to the operating end, and the traction section is used to pull the tie section so that the tie section drives the open end to gather.

[0010] Furthermore, a fixing ring is fixed on the slender supporting body, and the fixing ring is located at the proximal end of the filter; a through hole is provided on the fixing ring, and the traction section extends to the operating end after passing through the through hole.

[0011] Furthermore, the filter includes a filter membrane and a filter membrane support for the filter membrane, the distal end of the filter membrane support is fixed on the slender support body or the filter membrane support is fixed on the tether, the proximal end of the filter membrane support can expand radially outward relative to the slender support body after the external force is withdrawn, and the filter membrane support presents a single cone configuration with the opening located at the proximal end after radially expanding outward; a plurality of rope threading holes are arranged at the proximal end of the filter membrane.

[0012] Furthermore, the filter membrane is made of a polymer film material, and filter holes are arranged on the filter membrane, and the pore size of the filter holes ranges from 50 microns to 500 microns.

[0013] Furthermore, one end of the cuff segment is connected to the traction segment and the other end is connected to the fixed segment, and the other end of the fixed segment is fixedly connected to the fixed ring; or both ends of the cuff segment are connected to the traction segment, and both traction segments extend to the operating end after passing through the through hole.

[0014] Furthermore, the filter includes a filter mesh formed by braided wire; the distal end of the filter mesh is fixed on the slender supporting body, the proximal end of the filter mesh is woven to form an end braiding structure, the rope threading hole is a braided hole formed by the end braiding structure, and the tie rope end section passes through multiple braided holes.

[0015] Furthermore, the two ends of the draw-off section are connected to form a ring, and the draw-off section alternately passes through a plurality of woven holes on the end woven structure; the parts where the two ends of the draw-off section are connected form a buttonhole, and the traction section passes through the buttonhole; when the filter net is in an expanded configuration and the operating end pulls the tether toward the proximal end, the traction section pulls one end of the draw-off section through the buttonhole to shrink or close the opening formed by the draw-off section and the end woven structure.

[0016] The technical solution of the present invention has the following advantages: the embolic protection device is provided by tying a tether to the open end of the proximal end of the filter, and extending at least one end of the tether to the operating end; when the filter is released and expanded outward to form an expanded configuration, the proximal end of the filter is an open end, and the thrombus can enter the filter through the opening formed by the open end; when the filter and the thrombus in the filter need to be withdrawn from the body, at least one end of the tether is pulled toward the proximal end through the operating end, and the tether is pulled to drive the open end to gather, thereby reducing or even completing the opening formed by the closed open end, so that the thrombus is wrapped in the filter, thereby reducing the risk of thrombus escape. In addition, when the filter is released and in an expanded configuration, the tether supports the filter through the shape memory property, so that the filter fits the inner wall of the blood vessel. Since at least one end of the tether is movable, the outer diameter of the filter in the expanded configuration is adjustable, thereby adapting to different blood vessel diameters, simplifying the surgical steps, and facilitating the operator's operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 is a schematic diagram of the three-dimensional structure of the filter of the embolic protection device in the first embodiment of the present invention when it is in an expanded configuration; Figure 2 is a front view of the filter of the embolic protection device in the first embodiment of the present invention when it is in the expanded configuration; Figure 3 for Figure 2 A cross-sectional view of Figure 4It is a schematic diagram of the three-dimensional structure of the filter of the embolic protection device in the first embodiment of the present invention when the open end of the filter is in a gathered state; Figure 5 is a schematic diagram of the three-dimensional structure of the filter of the embolic protection device in the second embodiment of the present invention when it is in an expanded configuration; Figure 6 It is a schematic diagram of the three-dimensional structure of the filter of the embolic protection device in the second embodiment of the present invention when the open end of the filter is in a gathered state; Figure 7 Schematic diagram of the connection relationship between the proximal end of the filter screen and the tether in the second embodiment of the present invention.

[0019] Explanation of the reference numerals: 1. guide wire; 2. filter; 2a. closed end; 2b. open end; 2c. gathered end; 21. filter membrane; 211. filter hole; 22. filter net; 221. end braided structure; 3. fixing ring; 4. tether; 4a. constriction section; 4b. traction section; 4c. fixing section. DETAILED DESCRIPTION

[0020] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] In the description of this application, it should be understood that the terms "proximal end" and "distal end" used throughout the text refer to near and far relative to the operator. When the present invention is used, the end close to the doctor or operator is the "proximal end", that is, the end where the operator is located, and the end away from the doctor or operator is the "distal end", that is, the end where the balloon is located. The above-mentioned description of the orientation is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0022] Embodiment 1 like Figure 1-Figure 4An embolic protection device shown includes a slender support body, a filter 2 and a catheter (not shown). The slender support body is specifically a guidewire 1, and the filter 2 is sleeved and connected to the outer periphery of the guidewire 1. The inner lumen of the catheter can allow the guidewire 1 to pass through; the embolic protection device transports the filter 2 to the distal position in the diseased blood vessel through the guidewire 1. The filter 2 is specifically a deformable structure with the distal end fixed on the guidewire 1, and the filter 2 has a recovery state accommodated in the catheter and a release state extending out of the catheter; when the filter 2 is released from the catheter, the filter 2 is radially outwardly expanded relative to the guidewire 1 to form an expanded configuration; at this time, the distal end of the filter 2 is a closed end 2a, and the proximal end of the filter 2 is an open end 2b, and the open end 2b is formed with an opening for the thrombus to enter the filter 2, and the closed end 2a forms a seal that can hold the thrombus. In other alternative embodiments, the slender support body can also be a slender catheter.

[0023] like Figure 1 , Figure 2 and Figure 3 As shown, a fixing ring 3 located at the proximal end of the filter 2 is fixed on the guide wire 1, and a through hole is provided on the fixing ring 3. The embolic protection device also includes a tether 4 tied to the open end 2b of the filter 2, one end of the tether 4 passes through the through hole on the fixing ring 3 and extends to the operating end, and the other end of the tether 4 is fixed on the fixing ring 3. The fixing ring 3 is used to limit the position of the tether 4 forming a circle on the open end 2b, and the through hole on the fixing ring 3 is used to limit the tether 4 extending axially along the guide wire 1 to the operating end. The tether 4 can drive the open end 2b of the filter 2 to gather to reduce or completely close the opening formed by the open end 2b. This embolic protection device is configured by tying a tether 4 on the open end 2b of the filter 2. When the filter 2 and the thrombus in the filter 2 need to be withdrawn from the body, the tether 4 is pulled toward the proximal end through the operating end. After the tether 4 is pulled, the open end 2b is brought together, thereby shrinking the open end 2b to form an opening or even completely closing the opening formed by the open end 2b, so that the thrombus is wrapped in the filter 2, thereby reducing the risk of thrombus escape during the withdrawal of the embolic protection device from the body.

[0024] like Figure 1-Figure 4As shown, the open end 2b has an open state of keeping the opening open and a gathered state of gathering the opening under the action of the tether 4. The tether 4 is a memory alloy wire with a shape memory function, for example, the tether 4 is a nickel-titanium alloy wire; or the tether 4 is a memory alloy developing wire with both shape memory function and developing function, for example, the tether 4 is a nitinol alloy wire formed by adding tantalum, platinum, gold, iridium, tungsten and other elements to the nickel-titanium alloy. Under the action of the tether 4, the filter 2 can fit the blood vessel wall while adapting to different blood vessel diameters, and locate the position of the open end 2b of the filter 2 through development. When the filter 2 is released to an expanded configuration, the tether 4 can provide a certain support force for the open end 2b of the filter 2, so that the open end 2b of the filter 2 can be kept in an open state of opening after the filter 2 is released, and at this time, the open end 2b of the filter 2 fits the inner wall of the blood vessel. Using a shape memory alloy wire as the tether 4 can not only provide a certain support effect for the open end 2b of the filter 2, so that the open end 2b can remain open, which is convenient for thrombus to enter the filter 2 and improves the thrombus collection effect of the filter 2; and because at least one end of the tether 4 is movable, the tether 4 can also make the open end 2b of the filter 2 fit the inner wall of blood vessels of different diameters. When the filter 2 is in the expanded configuration and the operating end pulls the tether 4 toward the proximal end, the tether 4 drives the open end 2b to gather so that the open end 2b is converted from an open state to a gathered state, and the opening enclosed by the open end 2b is reduced or completely closed. The shape of the open end 2b of the filter 2 when it is completely closed is as follows: Figure 4 As shown, at this time, the open end 2b of the filter 2 is gathered to form a gathered end 2c wrapped around the outer periphery of the guide wire 1, and the thrombus in the filter 2 cannot escape.

[0025] like Figure 1 , Figure 2 and Figure 3 As shown, the filter 2 includes a filter membrane 21 and a filter membrane support (not shown) for supporting the filter membrane 21. The distal end of the filter membrane support is fixed on the guide wire 1. The proximal end of the filter membrane support can be radially expanded outward relative to the guide wire 1 after the external force is withdrawn. After the filter membrane support is radially expanded outward, it presents a single cone configuration with the opening located at the proximal end. The filter membrane 21 is a polymer film attached to the filter membrane support. The distal end of the filter membrane 21 forms a conical closed opening, and the proximal end of the filter membrane 21 forms a cylindrical open opening. The filter membrane 21 is provided with a plurality of filter holes 211 for blood flow to pass through, and the pore size of the filter holes 211 ranges from 50 microns to 500 microns. In an alternative embodiment, the filter membrane support can also be fixed on the tether 4 or the fixing ring 3. In this case, the filter membrane support is a memory alloy support with a morphological memory function. After the filter 2 is released, the filter membrane support radially expands outward under the action of its own morphological memory function.

[0026] Specifically, the filter membrane 21 is made of a polymer film material that is punched and then shaped. The material of the filter membrane 21 can be polypropylene (PP), polyvinyl chloride (PVC), polyamide (nylon), polyurethane, polyester, polyethylene terephthalate (PET), polyether block amide (PEBA), polytetrafluoroethylene (PTFE) or a mixture, blend or combination thereof.

[0027] Specifically, the filter membrane support can be a single cone-shaped support composed of multiple support wires, the multiple support wires are evenly spaced around the guide wire 1, and the distal ends of the multiple support wires are fixed on the guide wire 1. In an alternative embodiment, the filter membrane support can also be a woven mesh structure woven from one or more metal wires and capable of radial expansion or contraction under the action of external force.

[0028] like Figure 2 and Figure 3 As shown, the tether 4 includes a tie segment 4a circumferentially arranged around the open end 2b and a traction segment 4b connected to one end of the tie segment 4a, the tie segment 4a is used to gather the open end 2b of the filter 2, the other end of the traction segment 4b extends to the operating end, and the traction segment 4b is used to pull the tie segment 4a so that the tie segment 4a drives the open end 2b of the filter 2 to gather.

[0029] In some embodiments, the open end 2b of the filter membrane 21 is provided with a plurality of rope threading holes arranged along its circumference, and the tie-end section 4a is passed through the plurality of rope threading holes. After the tether 4 is pulled, the length of the tie-end section 4a bound to the open end 2b is shortened, so that the tie-end section 4a drives the open end 2b to gather. It should be noted here that the tie-end section 4a and the traction section 4b of the tether 4 are integrated, and the tie-end section 4a and the traction section 4b are defined according to the positions of the various parts of the tether 4. The tie-end section 4a is defined as the part of the tether 4 bound to the open end 2b and arranged circumferentially around the open end 2b, and the traction section 4b is the part of the tether 4 connected to the operating end and pulling the tie-end section 4a; when the tether 4 is pulled toward the proximal end, a part of the tie-end section 4a originally bound to the open end 2b is no longer bound to the open end 2b and becomes a part of the traction section 4b. In other alternative embodiments, the filter membrane 21 along the edge of the opening is folded outward or inward to form a flange, and a cuff track is formed between the flange and the filter membrane 21. A notch is provided on the flange, and the cuff segment 4a passes through the cuff track and goes around the edge of the opening. Both ends of the cuff segment 4a extend out of the notch, and one end of the cuff segment 4a is connected to the traction segment 4b, and the other end of the cuff segment 4a is fixed. When the traction segment 4b of the tether 4 is pulled, a portion of the cuff segment 4a is pulled out of the cuff track, so that the cuff segment 4a drives the open end 2b to gather.

[0030] like Figure 2 and Figure 3As shown, in some embodiments, the tether 4 also includes a fixed section 4c, one end of which is connected to one end of the tie-mouth section 4a and the other end is fixedly connected to the fixing ring 3, and one end of the traction section 4b is connected to the tie-mouth section 4a and the other end extends to the operating end after passing through the through hole. In other alternative embodiments, both ends of the tie-mouth section 4a are connected to the traction section 4b, and both traction sections 4b extend to the operating end after passing through the through hole. It should be noted here that the fixed section 4c, the tie-mouth section 4a and the traction section 4b are defined according to the positions of the various parts of the tether 4, and the fixed section 4c is defined as the part of the tether 4 fixed to the fixing ring 3 and extending to the open end 2b of the filter 2.

[0031] Embodiment 2 like Figure 5-7 The embolic protection device shown is different from the first embodiment in that the filter 2 includes a filter mesh 22 woven from braided wires, and there is no filter membrane 21 on the filter mesh 22. The thrombus is intercepted by the filter mesh 22, and the mesh of the filter mesh 22 allows blood flow to pass through. The distal end of the filter mesh 22 is fixed on the guide wire 1. After being released from the catheter, the filter mesh 22 can be expanded radially outward relative to the guide wire 1. After the filter mesh 22 is expanded radially outward, it presents a single cone configuration with the opening located at the proximal end. The proximal end of the filter mesh 22 is woven to form an end braided structure 221, and the end braided structure 221 is formed with a plurality of braided holes arranged circumferentially around the opening, and the tie-end section 4a of the tether 4 passes through the plurality of braided holes.

[0032] In this embodiment, the two ends of the tie-mouth segment 4a are connected to form an annular nitinol-tantalum alloy ring, and the tie-mouth segment 4a alternately passes through a plurality of braided holes on the end braided structure 221; for example, the tie-mouth segment 4a is located on the outside of the braided wire once, and is located on the inside of the braided wire the next time it passes through the braided hole. The part where the two ends of the tie-mouth segment 4a are connected forms a buttonhole, and the traction segment 4b passes through the buttonhole. When the filter 2 is released, the nitinol-tantalum alloy ring can fit the blood vessel wall and provide support for the proximal opening of the filter net 22; when the operating end pulls the tether 4 toward the proximal end, the traction segment 4b can pull one end of the tie-mouth segment 4a through the buttonhole to adjust the size of the opening formed by the tie-mouth segment 4a, thereby adapting to the inner wall of the blood vessel or reducing or even closing the proximal opening of the filter net 22.

[0033] In summary, the embolic protection device provided by the embodiment of the present invention is provided by tying a tether 4 to the open end 2b at the proximal end of the filter 2, and extending at least one end of the tether 4 to the operating end; when the filter 2 is released and expanded outward to form an expanded configuration, the proximal end of the filter 2 is the open end 2b, and the thrombus can enter the filter 2 through the opening formed by the open end 2b; when the filter 2 and the thrombus in the filter 2 need to be withdrawn from the body, at least one end of the tether 4 is pulled toward the proximal end through the operating end, and the tether 4 is pulled to drive the open end 2b to gather, thereby reducing or even completing the opening formed by the closed open end 2b, so that the thrombus is wrapped in the filter 2, thereby reducing the risk of thrombus escape. In addition, when the filter 2 is released and in an expanded configuration, the tether 4 supports the filter 2 through the shape memory property, so that the filter 2 fits the inner wall of the blood vessel. Since at least one end of the tether 4 is movable, the outer diameter of the filter 2 in the expanded configuration is adjustable, thereby adapting to different blood vessel diameters, simplifying the surgical steps, and facilitating the operator's operation.

[0034] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. An embolic protection device, characterized in that: include: A slender support body; A filter (2) is sleeved on the outer periphery of the slender support body, and the filter (2) has an expanded configuration that expands radially outward relative to the slender support body; the distal end of the filter (2) is a closed end (2a), and the proximal end of the filter (2) is an open end (2b); when the filter (2) is in the expanded configuration, the open end (2b) forms an opening for a thrombus to enter the filter (2), and the closed end (2a) forms a seal that holds the thrombus; A tether (4) is tied to the open end (2b) of the filter (2), and at least one end of the tether (4) extends to the operating end; the tether (4) is used to drive the open end (2b) to gather under the control of the operating end to reduce or close the opening; The tether (4) comprises a cinch section (4a) circumferentially arranged around the open end (2b), at least one end of the cinch section (4a) is connected to a traction section (4b) extending to the operating end, and the traction section (4b) is used to pull the cinch section (4a) so that the cinch section (4a) drives the open end (2b) to gather.

2. The embolic protection device according to claim 1, characterized in that: When the filter (2) is in the expanded configuration and the operating end does not pull the tether (4) toward the proximal end, the tether (4) provides support for the open end (2b) of the filter (2) so that the open end (2b) remains in an open state; when the filter (2) is in the expanded configuration and the operating end pulls the tether (4) toward the proximal end, the tether (4) drives the open end (2b) to gather to reduce or close the opening.

3. The embolic protection device according to claim 2, characterized in that: The tether (4) is a memory alloy wire having a shape memory function, or the tether (4) is a memory alloy developing wire having both a shape memory function and a developing function.

4. The embolic protection device according to any one of claims 1 to 3, characterized in that: The open end (2b) of the filter (2) is provided with a plurality of rope threading holes arranged along its circumference, and the tie-mouth section (4a) is passed through the plurality of rope threading holes.

5. The embolic protection device according to claim 4, characterized in that: A fixing ring (3) is fixed on the slender supporting body, and the fixing ring (3) is located at the proximal end of the filter (2); a through hole is provided on the fixing ring (3), and the traction section (4b) extends to the operating end after passing through the through hole.

6. The embolic protection device according to claim 5, characterized in that: The filter (2) comprises a filter membrane (21) and a filter membrane support for supporting the filter membrane (21); the distal end of the filter membrane support is fixed on the slender support body or the filter membrane support is fixed on the tether (4); the proximal end of the filter membrane support can be radially expanded outward relative to the slender support body after the external force is withdrawn; the filter membrane support, after radially expanding outward, presents a single cone configuration with an opening located at the proximal end; and a plurality of rope threading holes are arranged at the proximal end of the filter membrane (21).

7. The embolic protection device according to claim 6, characterized in that: The filter membrane (21) is made of a polymer film material. The filter membrane (21) is provided with filter holes (211). The pore size of the filter holes (211) ranges from 50 micrometers to 500 micrometers.

8. The embolic protection device according to claim 5, characterized in that: One end of the cinch section (4a) is connected to the traction section (4b), and the other end is connected to the fixed section (4c), and the other end of the fixed section (4c) is fixedly connected to the fixed ring (3); or both ends of the cinch section (4a) are connected to the traction section (4b), and both traction sections (4b) pass through the through hole and extend to the operating end.

9. The embolic protection device according to claim 5, characterized in that: The filter (2) comprises a filter net (22) woven from braided wires; the distal end of the filter net (22) is fixed on the slender supporting body, the proximal end of the filter net (22) is woven to form an end braided structure (221), the rope threading hole is a braided hole formed by enclosing the end braided structure (221), and the tie-end section (4a) of the tether (4) passes through a plurality of braided holes.

10. The embolic protection device according to claim 9, characterized in that: The two ends of the cuff segment (4a) are connected to form a ring, and the cuff segment (4a) alternately passes through a plurality of woven holes on the end woven structure (221); the parts where the two ends of the cuff segment (4a) are connected form a buttonhole, and the traction segment (4b) passes through the buttonhole; when the filter net (22) is in an expanded configuration and the operating end pulls the tether (4) toward the proximal end, the traction segment (4b) pulls one end of the cuff segment (4a) through the buttonhole to reduce or close the opening formed by the cuff segment (4a) and the end woven structure (221).

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