JP2018102725A - Hemostatic instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a hemostatic instrument with high operability, capable of quickly arresting hemorrhage at an injured part of a blood vessel, while securing a sufficient blood flow by a low-invasive and percutaneous approach without especially requiring an appropriate supply operation such as gas in emergencies.SOLUTION: A hemostatic instrument 100 includes: a cylindrical braided-body (a mesh stent 1) formed by braiding wires 1a; a first shaft (an inner tube 2) in which one end in the axial direction of the braided body is fixed to a distal end thereof; and a cylindrical second shaft (an outer tube 3) in which the other end in the axial direction of the braided body is fixed to the distal end thereof. At least any one of the first shaft and the second shaft is moved in a direction relatively not overlapped with the axial direction, so that the braided body is extended in the axial direction and reduced in the radial direction to be able to be inserted/retracted with respect to the blood vessel. At least one of the first shaft and the second shaft is moved in a direction relatively overlapped with the axial direction, so that the braided body is reduced in the axial direction and expanded in the radial direction so as to cover an injured part of the blood vessel.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a hemostatic device that covers a damaged portion of a blood vessel from the inside of a blood vessel of a living body and stops bleeding.

  For traumatic injuries of the inferior vena cava of the liver, it is often difficult to stop hemostasis of the damaged part by existing treatment methods such as suture repair and gauze packing. Although there are reports of treatment using stent grafts as endovascular treatments for the above-mentioned damage, there are no vein-only stent grafts in Japan and overseas, and currently, stent grafts developed for the aorta are substituted. is there. This treatment results in a high risk of graft occlusion in the long term because the stent graft is permanently placed in the vessel. In addition, complications such as movement and breakage of the stent graft may occur. Because long-term placement results are unknown because stent grafts are relatively new devices, their use in young people is never recommended.

  As an intravascular treatment other than the above, there is a treatment using a hemostatic shunt device described in Patent Document 1, for example. The hemostatic shunt device described in Patent Document 1 includes a distal balloon and a proximal balloon that can be inflated to a size that can block the blood flow of the inferior vena cava, a lumen that serves as a blood bypass, and the balloon. A hose having a lumen for supplying gas or the like. The distal balloon is attached to the hose distal side and the proximal balloon is attached to the hose proximal side.

  By inflating the distal balloon and the proximal balloon of the hemostatic shunt device inserted into the inferior vena cava, the portion between the distal balloon and the proximal balloon is hemostatic. It is said that the lumen of the inferior vena cava is maintained by the lumen that serves as a blood bypass.

  By using the above-mentioned hemostatic shunt device, it is possible to quickly stop bleeding from the portal vein, inferior vena cava, or hepatic vein due to liver damage while maintaining the return to the heart. Patent Document 1 describes that an operation for repairing a patient can be performed accurately and quickly.

JP 2016-36468 A

  In the treatment using the hemostatic shunt device described in Patent Document 1, in order to inflate the distal balloon and the proximal balloon, an appropriate supply operation of gas or the like to these balloons is essential. In addition, it may be difficult to perform a fine adjustment operation of the positions of the distal balloon and the proximal balloon and an operation of appropriately inflating these balloons in cooperation with each other. In addition, traumatic hemorrhage significantly reduces circulating blood volume, and blocking the inferior vena cava blood flow under this circumstance can easily cause cardiac arrest. In order to avoid this, it is necessary to secure the inferior vena cava blood flow by a lumen that constitutes a blood bypass path that constitutes the hemostatic shunt device, but this requires a large-diameter lumen (a small-diameter lumen). Then, it is difficult to secure sufficient inferior vena cava blood flow). In addition, when a large-diameter lumen is used, percutaneous placement that is minimally invasive is difficult, placement is required under highly invasive laparotomy, and the procedure is complicated.

  The present invention has been made in view of the above circumstances, and the purpose thereof is sufficient in a transcutaneous approach that is minimally invasive and does not require an appropriate supply operation of gas or the like in an emergency. An object of the present invention is to provide a hemostatic device with excellent operability that can quickly stop a damaged part of a blood vessel while ensuring blood flow.

  The present invention is a hemostatic device that covers a damaged portion from the inside of a blood vessel and stops hemostasis. The hemostasis device has a cylindrical knitted body in which wires are braided and a form in which a part is coaxially inserted into the knitted body, and one end in the axial direction of the knitted body is the tip. A first shaft fixed to the portion, and a cylindrical shape coaxial with the first shaft and covering the first shaft from the outside, the other end portion of the knitted body in the axial direction being fixed to the tip portion A second axis. By moving at least one of the first axis and the second axis in a direction in which the first axis and the second axis do not overlap with each other in the axial direction, It extends in the axial direction and is reduced in diameter in the radial direction so that it can be inserted into and removed from the blood vessel. At least one of the first axis and the second axis is the first axis and the second axis. Is moved in a direction relatively overlapping in the axial direction, the knitted body shrinks in the axial direction and expands in the radial direction to cover the damaged portion.

  According to the hemostasis device according to the present invention, it is possible to hemostasis a damaged portion of a blood vessel without particularly needing to supply gas or the like. Further, the first shaft and the second shaft are moved integrally, or one shaft is moved relative to the other shaft, so that the fine adjustment operation of the position of the knitted body and its diameter expansion are performed. Operations can be performed in conjunction with each other. That is, the hemostasis device according to the present invention is excellent in operability and can quickly stop a damaged portion of a blood vessel in an emergency. In addition, when the knitted body expands in the radial direction and covers the damaged part of the blood vessel, the stitches at both ends in the axial direction of the knitted body widen, so that the damaged part can be hemostatic while ensuring sufficient blood flow. can do. Further, since the knitted body is reduced in diameter in the radial direction, the knitted body is reduced in diameter, and a percutaneous approach that is minimally invasive is possible.

FIG. 1A is a schematic side view showing a hemostasis device according to an embodiment of the present invention, FIG. 1A is a side view of a state in which a knitted body is extended, and FIG. 1B is a state in which the knitted body is contracted. FIG. It is a top view around the holding part of Fig.1 (a). It is the A section expanded sectional view of Drawing 1 (a). It is the photograph which image | photographed the state which the front end side part of the knitted body of the state expanded in the axial direction and diameter-reduced from the guide tube in the blood vessel was simulated on the desk. It is the photograph which image | photographed on the desk imitating the state by which the front end side part of the knitted body extended in the axial direction and diameter-reduced was inserted to the damaged part of the blood vessel. By moving the second shaft from the state shown in FIG. 5 to the tip side, the diameter of the knitted body expands at the damaged part of the blood vessel, so that the state where the damaged part of the blood vessel is covered with the knitted body is simulated on a desk. It is a photograph taken by. FIG. 7A is a photograph of the knitted body in a reduced diameter state as seen from the axial direction, and FIG. 7B is a photograph of the knitted body in an enlarged state as seen from the axial direction. is there.

  Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings.

(Configuration of hemostatic device)
Based on FIGS. 1-3, the structure of the instrument 100 for hemostasis based on one Embodiment of this invention is demonstrated. The hemostasis device 100 is a hemostasis device that covers the damaged portion from the inside of a blood vessel and stops hemostasis, and is a mesh stent 1 as a knitted body, an inner tube 2 as a first shaft, and a cylindrical second shaft. As an outer tube 3 and a grip portion 4.

  The mesh stent 1 is a cylindrical knitted body formed by braiding a plurality of wires 1a. One end portion in the axial direction of the mesh stent 1 is bundled with a plurality of wires 1a and fixed to the distal end portion of the inner tube 2 by a fixing bracket 9 (see FIG. 1). The other end portion in the axial direction of the mesh stent 1 is bundled with a plurality of wires 1a and fixed to the distal end portion of the outer tube 3 by a fixing fitting 10 (see FIGS. 1 and 3).

  The material of the wire 1a constituting the mesh stent 1 is, for example, a shape memory alloy, specifically, for example, a nickel-titanium alloy. The wire 1a has a diameter of, for example, 5 μm to 200 μm. It is also possible to use a SUS316 wire as the wire 1a. Furthermore, it is also possible to form a mesh stent using a wire material made of a resin material such as carbon fiber or aramid fiber instead of a metal wire material such as nickel-titanium alloy or SUS316. The wire 1a is made of a cylindrical shape when the diameter of the mesh stent 1 is expanded, and when used in combination with an operation that compresses the organ from the outside, such as gauze packing, the blood vessel of the indwelling portion is blocked against the pressure of the organ compression. Any material can be used as long as the material can maintain the lumen sufficiently, reduce the blood flow in the radial direction to stop hemostasis, and ensure the axial blood flow.

  The mesh stent 1 is formed by braiding a plurality of wires 1a into a cylindrical shape by, for example, a method called a fourth stitch, a braided braid, or the like. For example, the mesh stent 1 is formed by braiding 24 to 144 (preferably a multiple of 4) wire rods 1a into a cylindrical shape while crossing each other. The portions where the wire rods 1a intersect may be coupled to each other, but are preferably not coupled to each other in order to ensure the degree of freedom of axial expansion and contraction and radial expansion and contraction. A cylinder that expands in the radial direction when it extends in the axial direction, and expands in the radial direction when it contracts in the axial direction by braiding around the cylindrical object while crossing the plurality of wires 1a. A mesh stent 1 is formed.

  The outer diameter of the mesh stent 1 when the diameter is reduced (see FIG. 1A) is, for example, 3 to 10 mm. On the other hand, the outer diameter (outer diameter of the cylindrical portion) of the mesh stent 1 when the diameter is expanded (see FIG. 1B) is, for example, 20 to 30 mm. Note that the outer diameter of the mesh stent 1 when the diameter is expanded is determined in accordance with the inner diameter of the blood vessel to be stopped (for example, the vena cava below the liver).

  The mesh stent 1 is expanded when the diameter of the mesh stent 1 is increased so that the diameter of the mesh stent 1 is sufficiently reduced in the radial direction by extending in the axial direction and a large shape collapse due to repeated expansion and contraction in the axial direction does not occur as much as possible. In consideration of the outer diameter, the material, diameter (wire diameter), number, and knitting method of the wire 1a are determined.

  It is possible to form a coil spring-like cylindrical mesh stent by winding the wire 1a in only one direction in a coil shape (spiral), but in this case, the cylindrical shape of the mesh stent when the diameter is expanded Is difficult to maintain sufficiently. In addition, in a coil spring-shaped mesh stent in which the wire 1a is wound only in one direction, a force that tends to twist about the axial direction may be generated when the mesh stent is stretched or contracted in the axial direction. . This force is transmitted to the inner tube 2 and the outer tube 3 to which the mesh stent is fixed, and the inner tube 2 and the outer tube 3 try to rotate by the force. When such a torsional force acts on the inner tube 2 and the outer tube 3, not only is the operator difficult to operate the hemostatic device, but also the uniform cylindrical shape when the mesh stent is expanded (expanded diameter). It is difficult to position the stent accurately and effectively on the damaged part. On the other hand, since the mesh stent 1 is formed by braiding the wire 1a, the twisting force as described above is less likely to be generated and deployed compared to the wire 1a wound in only one direction. When it does, it tends to become a uniform cylindrical shape.

  The inner tube 2 is an elongated tube, and the material thereof is, for example, SUS316. The outer diameter of the inner tube 2 is about 1 mm, for example. The inner tube 2 is partially inserted into the mesh stent 1 coaxially. As described above, one end portion in the axial direction of the mesh stent 1 is fixed to the distal end portion of the inner tube 2. An end member 5 is attached to the rear end portion of the inner tube 2. A hole 5 a communicating with the hole 2 a of the inner tube 2 is formed at the end of the end member 5. A guide wire (0.035 inch diameter) can be passed through the hole 2a. By leading the guide wire under fluoroscopy, the hemostatic device 100 can be safely guided to the damaged part percutaneously. It becomes possible to do. The inner tube 2 side of the hole 5a is tapered. The material of the end member 5 is, for example, a transparent plastic.

  The outer tube 3 is an elongated tube, and the inner tube 2 is inserted therein. The outer tube 3 is coaxial with the inner tube 2 and covers the inner tube 2 from the outside. The inner tube 2 and the outer tube 3 constitute a double tube. The material of the outer tube 3 is, for example, SUS316. The outer diameter of the outer tube 3 is about 1.5 mm, for example. As described above, the other end portion in the axial direction of the mesh stent 1 is fixed to the distal end portion of the outer tube 3 (see FIG. 3). The rear end portion of the outer tube 3 is fixed in a state of being inserted into the conical tip portion 4 b of the grip portion 4.

  When at least one of the inner tube 2 and the outer tube 3 is moved in a direction in which the inner tube 2 and the outer tube 3 do not overlap with each other in the axial direction, the mesh stent 1 extends in the axial direction. At the same time, the diameter can be reduced in the radial direction and inserted into or removed from the blood vessel. Further, at least one of the inner tube 2 and the outer tube 3 is moved in a direction in which the inner tube 2 and the outer tube 3 are relatively overlapped in the axial direction, whereby the mesh stent 1 is moved in the axial direction. It shrinks and expands in the radial direction to cover the damaged part of the blood vessel from the inside.

  A portion on the distal end side of the inner tube 2, when the mesh stent 1 contracts in the axial direction to a predetermined length and overlaps with the axial center position of the mesh stent 1 in a side view by X-ray fluoroscopy. An identifiable identification unit 12 is provided (see FIG. 1B). The identification unit 12 is a part in which, for example, platinum, gold, cobalt, nickel, chromium, titanium, or an alloy thereof, and stainless steel are fixed to the outer peripheral surface of the inner tube 2 as a wire. Since these alloys and the like are metals that attenuate X-rays, the identification unit 12 can be identified by X-ray fluoroscopy. This identification part 12 is located in the center of the axial direction at the time of mesh stent 1 expansion | deployment (diameter expansion). In order to enhance the hemostatic effect, it is necessary to position the central portion of the mesh stent 1 developed (expanded) in the damaged portion. At this time, the identification portion 12 serves as a mark, and the mesh stent 1 can be accurately positioned. .

  The gripping portion 4 is a hollow cylinder attached to the outer tube 3 on the side opposite to the distal end portion (mesh stent 1 side) of the outer tube 3. The grip portion 4 includes a cylindrical grip portion main body 4a and a conical tip portion 4b. The material of the grip part 4 is, for example, plastic.

  A slit-shaped guide hole 11 extending in the axial direction is formed on the side surface of the grip portion main body 4a (see FIG. 2). The inner tube 2 is inserted through the outer tube 3 and the grip portion 4. A main body portion 6 a of the rotation preventing member 6 that is moved along the guide hole 11 is attached to a portion of the inner tube 2 that is inserted into the grip portion main body 4 a. The main body portion 6a has a cylindrical shape, and the outer diameter thereof is substantially equal to the inner diameter of the grip portion main body 4a. The main body portion 6a is fixed to the inner tube 2 in a state where the inner tube 2 is inserted through the central hole 6c of the cylindrical main body portion 6a. The main body 6a is movable in the axial direction along the inner surface of the gripping body 4a. On the side surface of the main body 6a, an operation knob 6b that can be held between fingertips protrudes. The knob portion 6b protrudes from the guide hole 11 to the outside of the grip portion main body 4a. The rotation preventing member 6 includes a cylindrical main body 6a and a knob 6b, and the material thereof is plastic, metal, or the like.

  A first shaft fixture 7 for preventing the inner tube 2 from moving in the axial direction relative to the outer tube 3 is attached to the rear end portion of the grip portion main body 4a. The first shaft fixture 7 includes a columnar main body portion 7a having a flange portion, and a knob portion 7b that is screwed into a side surface of the main body portion 7a, and the material thereof is plastic, metal, or the like.

  The main body portion 7a of the first shaft fixture 7 is inserted into the grip portion main body 4a from the rear end of the grip portion main body 4a, and is fixed to the rear end portion of the grip portion main body 4a. The inner tube 2 is inserted through the hole 7c at the center of the cylindrical main body 7a. The main body 7a and the inner tube 2 are not fixed. When the knob portion 7b is screwed into the main body portion 7a, the tip of the knob portion 7b is brought into contact with the inner tube 2, and the knob portion 7b is further screwed, the tip of the knob portion 7b and the hole of the main body portion 7a. The inner pipe 2 is sandwiched between the inner surface of 7c. Thereby, the inner tube 2 becomes difficult to move in the axial direction. When the force to be sandwiched between the inner pipes 2 (the screwing force of the knob portion 7b) is strong, the inner pipe 2 is fixed in the axial direction.

  In the hemostasis device 100 of the present embodiment, a liquid (for example, heparinized physiological saline for avoiding blood coagulation) is injected into the gap S (see FIG. 3) between the inner tube 2 and the outer tube 3. A liquid injection means 8 is provided. The liquid injected into the gap S is not limited to heparinized physiological saline.

  The liquid injection means 8 includes a columnar member 8a disposed in the distal end portion of the gripper body 4a, a nozzle 8c attached to a side surface of the columnar member 8a, and a hose 8b having a distal end inserted into the nozzle 8c. Have Inside the cylindrical member 8a, there is a space (flow path) (not shown) for flowing a liquid. The liquid injected into the hose 8b flows into the gap S between the inner tube 2 and the outer tube 3 after flowing in the cylindrical member 8a and the tip 4b of the grip portion 4 through the nozzle 8c. Since the tip of the outer tube 3 is open, the liquid flows out from the tip of the outer tube 3.

  Note that the shapes and structures of the grip portion 4, the end member 5, the rotation prevention member 6, and the first shaft fixture 7 are not limited to those described above.

(How to use hemostatic device)
A method of using the hemostatic device 100 will be described. In the following description, the inferior vena cava (hereinafter referred to as “inferior vena cava”) is the blood vessel to be hemostatic. The hemostatic device according to the present invention can also be applied to blood vessels such as the iliac vein. Furthermore, the present invention can be applied to closing an entry (disruption site of the intima and media, that is, an opening of a false cavity) in aortic dissection.

  The surgeon first punctures the femoral vein and places the sheath 50 as a guide tube (indicated by reference numeral 50 in the photographs of FIGS. 4 to 6). The inner diameter of the sheath 50 is about 4 mm, for example. Next, with the distal end portion of the hemostatic device 100 inserted into the sheath 50, the distal end of the guide wire is inserted into the inner tube 2 from the rear end of the inner tube 2 of the hemostatic device 100, so that X-ray fluoroscopy is performed. A guide wire is advanced below the inferior vena cava lesion to the superior vena cava. Thereafter, the mesh stent 1 side of the hemostatic device 100 is inserted into the blood vessel through the sheath 50 along the guide wire. At this time, the mesh stent 1 extends in the axial direction and has a reduced diameter by moving the knob portion 6b of the rotation preventing member 6 by pushing the grip portion 4 toward the inner side in the axial direction. (See FIG. 1 (a)). Since the mesh stent 1 has a reduced diameter, the mesh stent 1 is easily inserted into the sheath 50. Since the inner tube 2 has a certain degree of rigidity, the operator can extend the mesh stent 1 in the axial direction. In order to maintain the expanded state of the mesh stent 1, the knob portion 7 b of the first shaft fixture 7 is screwed into the main body portion 7 a of the first shaft fixture 7.

  When the mesh stent 1 is inserted into the sheath 50, heparinized physiological saline is injected into the gap S between the inner tube 2 and the outer tube 3 by the liquid injection means 8 as necessary ( Inject). This prevents blood from flowing back into the gap S and coagulating, so that the inner tube 2 and the outer tube 3 do not move relatively. The heparinized physiological saline functions as a lubricating liquid between the inner tube 2 and the outer tube 3. Further, when heparinized physiological saline flows out from the distal end portion of the outer tube 3, it functions as a lubricating liquid between the mesh stent 1 and the inner surface of the sheath 50, and the insertion of the mesh stent 1 becomes smooth.

  FIG. 4 is a photograph taken on a desk simulating a state in which the tip side portion of the mesh stent 1 that is extended in the axial direction and reduced in diameter in the radial direction protrudes from the sheath 50 in the blood vessel. .

  The mesh stent 1 in a reduced diameter state is advanced to the injured part of the inferior vena cava while confirming using X-ray fluoroscopy. An inferior vena cava angiography is performed using a previously placed indwelling catheter to confirm the inferior vena cava lesion. In some cases, it is possible to perform an inferior vena cava imaging through the inner tube 2 in a state where the mesh stent 1 is advanced to the lower hepatic inferior vena cava and the guide wire is removed. Thereafter, with the identification portion 12 of the mesh stent 1 positioned at the damaged portion (the state shown in FIG. 5), the operator loosens the knob portion 7b of the first shaft fixture 7 and moves the outer tube against the inner tube 2. 3 or the inner tube 2 is movable relative to the outer tube 3 in the axial direction, and the knob portion 6b of the anti-rotation member 6 is pulled forward in the axial direction with respect to the gripping portion 4, or the rear side in the axial direction. The identification part 12 is always positioned at the damaged part by pushing the grip part 4 toward the back side in the axial direction, pulling the grip part 4 toward the rear side in the axial direction, or moving the entire hemostatic device 100 back and forth. Thus, while finely adjusting the position of the mesh stent 1 in the axial direction, the diameter of the mesh stent 1 is gradually expanded by gradually moving the outer tube 3 toward the distal end side in the axial direction. Deployment (expansion) of the mesh stent 1 is performed under fluoroscopy. Thereby, the damaged part is covered with the mesh stent 1 from the inside of the inferior vena cava (the inferior vena cava is compressed and stopped from the inside) (the state shown in FIG. 6 is obtained). When the diameter of the mesh stent 1 is expanded at an appropriate position, the knob portion 7b of the first shaft fixture 7 is inserted into the main body portion 7a of the first shaft fixture 7 in order to maintain the state. Screw in.

  When the mesh stent 1 shrinks and expands, the stitches at both ends in the axial direction of the mesh stent 1 reversely expand (see FIG. 7B), and blood flow in the inferior vena cava is ensured. Since the stitches of the mesh stent 1 other than both axial ends, that is, the portion covering the damaged portion from the inside of the inferior vena cava is narrowed (closed), a hemostatic effect is obtained.

  The mesh stent 1 is removed from the inferior vena cava within 48 hours.

  The surgeon loosens the knob portion 7b of the first shaft fixture 7 and pulls the grip portion 4 toward the axial direction with respect to the knob portion 6b of the rotation preventing member 6, thereby extending and contracting the mesh stent 1 in the axial direction. Let the diameter. Next, the knob portion 7b of the first shaft fixture 7 is screwed into the main body portion 7a of the first shaft fixture 7 so that the mesh stent 1 is contracted in the axial direction and does not expand in diameter. Next, the mesh stent 1 is stored in the sheath 50 and is pulled out of the body and taken out.

  The inventor created a model of inferior vena cava damage to the porcine liver under general anesthesia, and placed the hemostatic device 100 in the damaged part. In all 6 cases in which the experiment was performed, it was confirmed by inferior vena cava angiography that the hemostasis effect and inferior vena cava blood flow were secured after the hemostatic device 100 was placed.

(Action / Effect)
According to the hemostasis device 100, it is possible to hemostasis a damaged portion of a blood vessel without particularly needing to supply gas or the like. Further, the inner tube 2 and the outer tube 3 are moved integrally, or one tube is moved relative to the other tube to finely adjust the position of the mesh stent 1 and its expansion. The diameter operations can be performed in conjunction with each other. That is, the hemostatic device 100 is excellent in operability and can quickly stop a damaged portion of a blood vessel in an emergency. In addition, when the knitted body expands in the radial direction and covers the damaged part of the blood vessel, the stitches at both ends in the axial direction of the knitted body widen, so that the damaged part can be hemostatic while ensuring sufficient blood flow. can do. Further, since the knitted body is reduced in diameter in the radial direction, the knitted body is reduced in diameter, and a percutaneous approach that is minimally invasive is possible.

  Further, the hemostatic device 100 is placed in the blood vessel, for example, after complete hemostasis is obtained in combination with the improvement of the general condition by intensive treatment including blood transfusion, that is, the blood vessel is about 48 hours after placement. Extracted from. In the event of rebleeding at the time of removal, it can be reinserted into the blood vessel and repositioned at the damaged site. Furthermore, in cases where hemostasis is difficult, it is possible to increase the hemostasis effect in combination with the existing gauze packing technique, and the hemostasis effect without causing deformation of the mesh stent 1 due to external pressure in the porcine hepatic inferior vena cava injury model Is confirmed to be obtained.

  The hemostatic device 100 includes a grip portion 4 having a slit-shaped guide hole 11 extending in the axial direction formed on a side surface, and the guide hole 11 is inserted into a portion of the inner tube 2 inserted into the grip portion main body 4a. An anti-rotation member 6 that is moved along is attached.

  According to this configuration, when the mesh stent 1 is contracted or stretched in the axial direction, the mesh stent 1 can be prevented from being twisted (having a spiral shape). As a result, when the diameter of the mesh stent 1 is expanded by shrinking in the axial direction, an appropriate cylindrical shape of the mesh stent 1 is easily maintained, and blood flow securing of the blood vessel and a hemostatic effect can be more reliably obtained. It is done.

  The hemostatic device 100 includes a first shaft fixture 7 for preventing the inner tube 2 from moving in the axial direction. According to this, the stretched state and the contracted state of the mesh stent 1 can be easily maintained.

  The inner tube 2 constituting the hemostatic device 100 is not a solid bar member but a cylindrical shape (cylinder). According to this, by inserting the guide wire into the inner tube 2, the inner tube 2, the outer tube 3, and the mesh stent 1 can be inserted into the blood vessel along the guide wire. As a result, it is possible to prevent the hemostatic device 100 from entering a blood vessel other than the inferior vena cava or damaging the inner wall of the blood vessel with the tip of the inner tube 2 or the like.

  The hemostatic device 100 further includes a sheath 50 (guide tube) that can be inserted into and removed from the blood vessel. The mesh stent 1 that extends in the axial direction and has a diameter reduced in the radial direction is inserted into and removed from the sheath 50 coaxially, so that the mesh stent 1 is inserted into and removed from the blood vessel percutaneously.

  An identification portion that is a portion on the distal end side of the inner tube 2 and that can be identified by X-ray fluoroscopy in a portion overlapping the mesh stent 1 in a side view when the mesh stent 1 is contracted in the axial direction to a predetermined length 12 is provided. According to this, the axial position of the mesh stent 1 can be easily aligned with the damaged part of the blood vessel by using the identification part 12 as a mark. In the above-described embodiment, the identification unit 12 is provided at a position overlapping the axial center position of the mesh stent 1 in a side view. By matching this identification part 12 with the damaged part of the blood vessel, the center part of the expanded (expanded diameter) mesh stent 1 can be easily positioned at the damaged part of the blood vessel. Since the mesh stent 1 cannot be moved for position adjustment when the diameter is completely expanded (there is a risk of blood vessel damage), the identification unit 12 is positioned at a position overlapping the axial center position of the mesh stent 1 in a side view. Is very effective.

  The hemostatic device 100 includes a liquid injection means 8 for injecting a liquid into the gap S between the inner tube 2 and the outer tube 3. According to this, the mesh stent 1 can be more smoothly inserted into the blood vessel. The liquid also functions as a lubricating liquid between the inner tube 2 and the outer tube 3.

(Modification)
The inner tube 2 may be an elongated solid bar member rather than an elongated tube. The liquid injection means 8 can be omitted.

  The mesh stent 1 may be inserted directly into the blood vessel without using the sheath 50.

  In the above-described embodiment, a position on the distal end side of the inner tube 2 that overlaps the axial center position of the mesh stent 1 in a side view when the mesh stent 1 is contracted in the axial direction to have a predetermined length. Further, an identification unit 12 that can be identified by X-ray fluoroscopy is provided. The position where the identification unit 12 is provided is not necessarily limited to the above position, and is a portion on the distal end side of the inner tube 2, and the side surface when the mesh stent 1 is contracted in the axial direction to a predetermined length. It may be a position overlapping the mesh stent 1 other than the axial center position of the mesh stent 1 when viewed.

  The hole 7c of the main body portion 7a of the first shaft fixture 7 may be a hole having a size that prevents the inner tube 2 from moving in the axial direction unless a certain amount of force acts on the inner tube 2. That is, the axial movement of the inner tube 2 may be prevented by the frictional force generated between the inner surface of the hole 7c of the main body portion 7a of the first shaft fixture 7 and the outer peripheral surface of the inner tube 2.

  The embodiments of the present invention and the modifications thereof have been described above. In addition, it is possible to make various changes within a range that can be assumed by those skilled in the art.

1: Mesh stent (knitted body)
1a: Wire 2: Inner pipe (first shaft)
3: Outer tube (second axis)
4: Gripping part 6: Anti-rotation member 7: First shaft fixture 8: Liquid injection means 11: Guide hole 12: Identification part 50: Sheath (guide tube)
100: Device for hemostasis

Claims (7)

A hemostatic device that covers the damaged part from inside the blood vessel and stops bleeding,
A cylindrical knitted body made of braided wire, and
A first shaft in which one end portion in the axial direction of the knitted body is fixed to a tip portion in a form in which a part thereof is coaxially inserted into the knitted body,
A cylindrical second shaft that is coaxial with the first shaft and covers the first shaft from the outside, and has the other end in the axial direction of the knitted body fixed to the tip.
With
By moving at least one of the first axis and the second axis in a direction in which the first axis and the second axis do not overlap with each other in the axial direction, It extends in the axial direction and shrinks in the radial direction, and can be inserted and removed from the blood vessel,
By moving at least one of the first axis and the second axis in a direction in which the first axis and the second axis are relatively overlapped with each other in the axial direction, A hemostatic device that shrinks in the direction and expands in the radial direction to cover the damaged part. The hemostatic device according to claim 1,
A hollow cylindrical grip attached to the second shaft on the opposite side of the tip of the second shaft;
A slit-shaped guide hole extending in the axial direction is formed on the side surface of the grip portion,
An instrument for hemostasis, wherein a rotation preventing member that is moved along the guide hole is attached to a portion of the first shaft that is inserted into the grip portion. The hemostatic device according to claim 1 or 2,
The hemostatic device further comprising a first shaft fixing tool for preventing the first shaft from moving in the axial direction. The hemostatic device according to any one of claims 1 to 3,
A hemostatic instrument, wherein the first shaft is cylindrical. The hemostatic device according to any one of claims 1 to 4,
A guide tube that can be inserted into and removed from the blood vessel;
The hemostasis device, wherein the knitted body, which extends in the axial direction and has a diameter reduced in the radial direction, is inserted into and removed from the blood vessel by being coaxially inserted into and extracted from the guide tube. The hemostatic device according to any one of claims 1 to 5,
Identification that can be identified by X-ray fluoroscopy in a portion on the tip side of the first shaft that overlaps the knitted body in a side view when the knitted body contracts in the axial direction to a predetermined length A device for hemostasis provided with a part. The hemostatic device according to any one of claims 1 to 6,
A hemostatic device further comprising a liquid injection means for injecting a liquid into a gap between the first shaft and the second shaft.