JP5650215B2 - Hemostatic device - Google Patents

Description

  The present invention relates to a hemostatic device for blocking hemostasis by closing an opening of a living body formed for medical purposes so as to communicate with a blood vessel such as a puncture site.

  When performing treatment in vivo using a catheter such as a balloon catheter, an introduction hole is formed by using an introduction needle or the like to reach the blood vessel through the patient's skin and muscle tissue. In addition, by arranging the introduction sheath with respect to the introduction hole, an introduction passage leading to the inside of the blood vessel is formed by the lumen in the introduction sheath. Then, the catheter is introduced through the lumen. In addition, when the treatment using the catheter is completed, the introduction sheath is removed after the catheter and the introduction device for introducing the catheter are taken out from the living body.

  In this case, the place where the introduction sheath is disposed is in a state in which an opening is formed from the skin to the blood vessel wall, and thus it is necessary to perform hemostasis. For example, in order to perform the hemostasis, a method of performing compression hemostasis by continuously applying an external force to the opening using gauze or the like is also conceivable. However, it is necessary to continue the compression and hemostasis state for a long time, which is a burden on the practitioner and the patient.

  On the other hand, for example, Patent Document 1 discloses a sealing device for closing the opening. Specifically, in a state where the introduction sheath is arranged, a hooking member having a hooking element at the tip portion is introduced, and the hooking element is hooked from the inside of the blood vessel to the inner wall of the blood vessel. Pull the hooking member outward. Thereafter, a cylindrical member in which a hemostatic member and an extruding member for extruding the hemostatic member are integrated is arranged in the introduction sheath, and after the arrangement, the cylindrical member and the introduction sheath are placed outside the body. And pull. At this time, due to the presence of the pushing member, the member for hemostasis is placed in the communication portion from the skin to the blood vessel wall. In addition, it is possible to perform an operation of placing the hemostatic member in a state where the member is used for positioning, with the hooking member being positioned by the hooking element. Thereafter, the introduction sheath is removed together with the hooking member, the pushing member, and the cylindrical member.

Special table 2008-518743 gazette

  Here, the hemostasis operation is a secondary operation performed after completion of treatment in the living body, and it is preferable that the operation is easily performed in view of the burden on the practitioner. However, in the technique disclosed in Patent Document 1, when the hooking member is inserted into the blood vessel, it is necessary for the practitioner to adjust the insertion amount, and the work is troublesome.

  This invention is made | formed in view of the said situation, and aims at providing the hemostatic instrument which can improve the workability | operativity of a hemostatic operation.

  Hereinafter, means and the like effective for solving the above-described problems will be described while showing functions and effects as necessary.

  The hemostatic device according to the first aspect of the present invention is a hemostatic device for performing hemostasis at a place where the introduction cylinder is disposed after performing the treatment with the introduction cylinder disposed through the tissue, wherein the introduction A cover cylinder having a cylindrical hole capable of accommodating a hemostatic member placed in the tissue in order to stop hemostasis at the placement location; and Provided at a position on the distal side of the covering cylinder so that it can be arranged on the distal side of the distal end portion, and in the blood vessel on the peripheral wall of the opening of the blood vessel wall into which the introducing cylinder is introduced A stopper formed so as to be able to transition to each of a locked state that can be brought into contact with the blood vessel wall and locked to the blood vessel wall, and a non-locked state that avoids the contact, and the introduction cylinder It is possible to position the hemostasis device relative to the introduction cylinder by contacting a part thereof. Then, when the positioning is performed, the positioning portion is provided so that the stopper in the non-locking state is disposed on the distal side of the distal end portion of the introducing cylinder. It is characterized by that.

  According to this configuration, when hemostasis is performed at an arrangement location of the introduction cylinder, the hemostasis device may be arranged at the arrangement location and the hemostasis member may be placed outside the introduction cylinder. Further, since the stopper is provided, it is possible to perform an operation for hemostasis while the hemostasis device is hooked, and the workability of the operation is improved.

  In this configuration, by positioning the hemostatic device with respect to the introduction cylinder using the positioning portion, the stopper in the non-locking state is naturally arranged on the distal side of the introduction cylinder. This eliminates the need to adjust the insertion amount of the hemostatic device into the blood vessel when starting the hemostatic operation using the hemostatic device, and improves the workability of the placement operation of the hemostatic device.

  Furthermore, since the stopper is provided so as to be disposed at a position distal to the cover cylinder, the stopper initially disposed in the cover cylinder is distal to the cover cylinder. Compared to a configuration in which a mechanism for displacing to the side position is provided, it is possible to achieve the above-described excellent effects while simplifying the configuration.

  The hemostasis device of the second invention: In the hemostasis device of the first invention, the hemostasis device of the first invention is provided so as to pass through the cylinder hole of the cover cylinder and extends more distally than the cover cylinder. A stopper support body having the stopper at a location and a support object integrated with the cover cylinder body are provided so as to be supported closer to the proximal end side than the cover cylinder body. In addition, the stopper support body supports a portion that is closer to the proximal end side than the cover cylinder, and is further displaceable with respect to the support object, and the stopper is held in the locked state and the through the displacement. And a stopper operating component that makes a transition between the non-locking state.

  According to this configuration, the stopper can be shifted between the locked state and the non-locked state by displacing the relative position of the stopper operation component with respect to the support target. The operation can be easily performed.

  The “support object in which the cover cylinder is integrated” means not only a configuration in which the cover cylinder is fixed so as not to be displaced relative to the support object, but also the cover cylinder cannot be displaced. A configuration in which the fixed predetermined member is supported so as to be displaceable with respect to the support target is also included.

  The hemostasis device of the third invention: In the hemostasis device of the second invention, the stopper transitions between the locking state and the non-locking state by itself expanding and contracting in the axial direction, The displacement range of the stopper operating component includes an initial position where the stopper is in the non-locking state and a locking position where the stopper is in the locking state.

  According to this configuration, when the stopper operating component is operated and displaced, the stopper itself expands and contracts and the transition between the locked state and the unlocked state is performed. The configuration can be simplified as compared with a configuration that requires.

  The hemostasis device of the fourth invention: The hemostasis device of the third invention, wherein the hemostasis device is provided so as to be interposed between the hemostasis member and the stopper support in the cylindrical hole of the cover cylinder. In addition, an interposer integrated with the support target is provided so as not to follow the displacement of the stopper support body accompanying the displacement of the stopper operation component.

  According to this configuration, the influence of the displacement of the stopper support body when the stopper is moved is received by the intervening body, and the influence of the displacement does not reach the hemostatic member. As a result, it is possible to prevent the hemostatic member from being displaced in the axial direction when the stopper is moved.

  The hemostatic device of the fifth invention: In the hemostatic device of the fourth invention, a part of the stopper is supported by the stopper support, and the other part is supported by the intervening body, When the stopper operating component is displaced with respect to the support object, the stopper operating component itself expands and contracts in the axial direction, and transitions between the locked state and the unlocked state.

  According to this configuration, it is possible to use the interposer as a member for expanding and contracting the stopper in the axial direction, and the configuration can be simplified as the interposer is multi-functionalized.

  A hemostatic device according to a sixth aspect of the invention: In the hemostatic device according to any one of the third to fifth aspects of the invention, a part of the stopper is supported by the stopper support body, and the other part is the stopper. The stopper operating component is provided so as to rotate around an axis in the process of being displaced from the initial position to the locking position. When the operating component is displaced from the initial position to the locking position, the rotational force around the axis of the stopper operating component is transmitted to the stopper through the stopper support, so that the stopper rotates around the axis. It is characterized by being twisted by.

  According to this configuration, when the stopper is in the locked state, the stopper is twisted around the axis more than in the non-locked state, so that it is possible to increase the locking force of the stopper in the locked state. It becomes. Further, since the locking force is naturally increased by changing the stopper from the non-locking state to the locking state, the operability is not lowered when the locking force is increased.

  A hemostatic device according to a seventh aspect of the present invention: the hemostatic device according to any one of the third to sixth aspects, wherein the urging means for urging the stopper operating component to one of the initial position and the locking position. It is characterized by having.

  According to this configuration, the biasing force of the biasing means can be used when the stopper operating component is displaced from one of the initial position and the locking position to the other. Improves.

  When the seventh invention is applied to the sixth invention, the stopper operating component may be urged toward the locking position by the urging means. In this case, when the stopper is brought into the locked state, not only a force for displacing the stopper operating component toward the locking position but also a force for twisting the stopper around the axis is required. The portion can be supplemented by the biasing means, and the operability can be improved.

  The hemostasis device of the eighth invention: The hemostasis device of any one of the second to seventh inventions, wherein the hemostasis device is provided so as to be movable in the axial direction within the tube hole of the cover cylinder, and A pushing member that discharges the hemostatic member from the distal end side opening of the cover cylinder to the outside of the cover cylinder by abutting from the proximal end side, and proximal to the cover cylinder A base part that supports the push-out member on the end side, and is provided so as to be supported by the base part, supports the cover cylinder, and can be displaced in the axial direction with respect to the base part. And a cover operating part having the positioning portion, wherein the stopper operating part is supported by the base part corresponding to the support target.

  According to this configuration, when the hemostasis operation is performed using the hemostasis device, the stopper operation component and the cover operation may be performed by performing the displacement operation of the stopper operation component with respect to the base component and the displacement operation of the cover operation component with respect to the base component. The operability is improved as compared with a configuration in which parts are individually provided. Further, since the displacement operation of the stopper operation component and the displacement operation of the cover operation component with respect to the base component can be performed separately, an operation of changing the state of the stopper and an operation of discharging the hemostatic member from the cover cylinder Can be performed independently.

  In addition, when this 8th invention is applied to the said 4th invention, it is good for the said base side support body to be set as the structure fixed to the said base component. As a result, when the cover operating component is operated to expose the hemostatic member, the cover operating component can be displaced relative to the hemostatic member while the base-side support is not displaced relative to the hemostatic member.

  The hemostatic device of the ninth invention: In the hemostatic device of the eighth invention, the relative position of the stopper operating part with respect to the base part includes an initial position where the stopper is in the non-locked state, and the stopper is engaged with the stopper. A locking position for stopping, and a relative position of the cover operating part to the base part is an initial position in which the hemostatic member is accommodated in the tube hole of the cover cylinder, A discharge position for discharging the hemostatic member to the outside of the cover cylinder by the action of the push member, and the stopper operating component is operated from the initial position by operating the stopper operating component. When the displacement is started toward the stop position, the stopper operating component needs to be rotated in a specific direction around the axis. It is formed so that it is necessary to rotate the base part in the direction opposite to the specific direction when the cover is operated to start the displacement from the initial position toward the discharge position. It is characterized by being.

  According to this configuration, when the stopper operating component is displaced from the initial position toward the locking position, even the cover operating component may be displaced from the initial position toward the discharging position. It is suppressed.

  The hemostatic device according to a tenth aspect of the invention: In the hemostatic device of the first aspect, the stopper is a balloon that expands when a fluid is supplied and contracts when the fluid is discharged. .

  In the configuration using a balloon as a stopper, the workability of hemostasis work is improved.

  The hemostatic device according to the eleventh aspect of the present invention: In the hemostatic device according to any one of the first to tenth aspects of the invention, the positioning portion includes a portion that creates an engagement relationship with the introduction cylinder. It is characterized by.

  According to this configuration, after the hemostatic device is positioned with respect to the introduction cylinder, it is possible to prevent the relative positions of the introduction cylinder and the hemostasis device from being shifted. Moreover, it becomes easy to perform an integral displacement operation between the introduction cylinder and the hemostatic device.

  The hemostatic device of the twelfth invention: In the hemostatic device of any one of the first to eleventh inventions, a pressing body is provided on the proximal end side of the hemostatic member in the cover cylinder, The hemostatic member and the pressing body are discharged from the opening on the distal end side of the cover cylinder to the outside of the cover cylinder when the cover cylinder is displaced toward the proximal end side. And is provided so as to be separable from the hemostatic device in the discharged state.

  According to this configuration, when the hemostatic member is separated from the hemostatic device, the pressing body is also separated together. Thereby, after separating the hemostatic member, it is possible to press the hemostatic member toward the hemostatic target portion using the pressing body.

It is a front view of a hemostatic instrument. (A)-(d) is a longitudinal cross-sectional view of a hemostatic device. (A1) is a front view of a stopper operating part to which a stopper shaft is fixed, (a2) is a longitudinal sectional view of the stopper operating part to which a stopper shaft is fixed, and (a3) is a stopper shaft to be fixed. (B1) is a front view of the base part to which the shaft unit is fixed, (b2) is a vertical cross-sectional view of the base part to which the shaft unit is fixed, c1) is a front view of the cover operating component to which the cover shaft is fixed, and (c2) is a longitudinal sectional view of the cover operating component to which the cover shaft is fixed. (A)-(d) is a figure for demonstrating the operation method of a hemostatic instrument. (A)-(d) is a figure for demonstrating the hemostatic method using the hemostatic instrument. (A)-(d) is a figure for demonstrating the hemostatic method using the hemostatic instrument. It is a front view of the hemostatic instrument of another form.

  DESCRIPTION OF EXEMPLARY EMBODIMENTS An embodiment of the invention will be described below with reference to the drawings. 1 is a front view of the hemostatic device 10, and FIGS. 2A to 2D are longitudinal sectional views of the hemostatic device 10 (the longitudinal section is a cross section in the direction along the axis), and FIGS. (C) is the front view and longitudinal cross-sectional view of each component which comprise the hemostatic device 10. FIG.

  As shown in FIGS. 1 and 2A, the hemostatic device 10 includes a plurality of main parts 11 to 13 and is formed in an elongated cylindrical shape having an axial direction as a longitudinal direction as a whole. Incidentally, FIG. 1 shows a state where the hemostatic device 10 is attached to an introduction sheath 50 as an introduction cylinder. The introduction sheath 50 is inserted into a puncture site formed from the patient's skin to the blood vessel, and enters the blood vessel of the medical device through the introduction sheath 50 during treatment using a medical device such as a catheter. Is introduced.

  As the plurality of main parts 11 to 13, the hemostatic device 10 is supported so as to be movable with respect to the base part 11 and the cover operation part 12 is moved by a manual operation of the operator. And a stopper operating component 13. The base component 11, the cover operation component 12, and the stopper operation component 13 are all formed using polycarbonate, and all are formed in a cylindrical shape so that the axial direction is the longitudinal direction. In addition, these components 11-13 may be formed using other synthetic resins, such as ABS resin (acrylonitrile butadiene styrene copolymer synthetic resin) and an olefin resin.

(Relationship between base part 11 and cover operation part 12)
First, the relationship between the base component 11 and the cover operation component 12 will be described.

  As shown in FIG. 2 (a), the base part 11 includes a base cylinder part 21 formed so that the outer diameter is constant over the entire axial direction, and a distal end part of the base cylinder part 21 ( And a guide protrusion 22 that is formed integrally with the hemostasis device 10 at the end of insertion into the patient and protrudes outward from the outer peripheral surface of the base tube portion 21. A plurality of guide protrusions 22 are formed at equal intervals around the axis, and specifically, two guide protrusions 22 are formed at intervals of 180 degrees. The cover operation component 12 is supported by the base component 11 using the pair of guide protrusions 22.

  The cover operation component 12 is formed so that the inner diameter thereof is the same from the opening of the proximal end portion (the end portion that becomes the insertion source when the hemostatic device 10 is inserted into the patient) to the middle position on the distal end side. Has been. The inner diameter of this part is set to be slightly larger than the outer diameter of the base cylinder part 21 in the base part 11, and the base part 11 is inserted into the cylinder hole of the cover operation part 12 from the opening of the proximal end part. Yes. In this case, the base part 11 and the cover operation part 12 are located on the same axis. Further, a guide groove 31 is formed in the cover operation component 12 so as to penetrate inside and outside. A plurality of guide grooves 31 are formed in one-to-one correspondence with the pair of guide protrusions 22 in the base part 11, and the guide protrusions 22 are in the respective guide grooves 31.

  The protrusion dimension (or height dimension) of the guide protrusion 22 is set to be larger than the depth dimension of the guide groove 31 (that is, the thickness of the cover operation component 12), and the tip of the guide protrusion 22 on the protrusion side. Exists outside the guide groove 31. The tip on the protruding side is formed wider than the leg portion extending in the protruding direction so as to widen the surface facing outward at the tip portion.

  As shown in FIGS. 3 (c1) and 3 (c2), the guide groove 31 is discontinuous at both ends in the axial direction with respect to both ends in the axial direction of the cover operating component 12. It is formed so as to exist in a region in the middle of the axial direction. Each guide groove 31 has a straight groove portion 31a extending linearly from the distal end side to the proximal end side of the cover operating component 12, and a direction around the axis from the proximal end portion of the straight groove portion 31a. A retreating groove 31b that enters in a direction orthogonal to the straight groove 31a, and both the grooves 31a and 31b are continuous. In each guide groove 31, the direction in which the retracting groove portion 31b enters from the straight groove portion 31a is the same direction. In addition, the dimension in the direction around the axis of the retracting groove 31b is set to be slightly larger than the dimension in the direction around the axis in the leg part of the guide projection 22.

  By forming the guide protrusion 22 and the guide groove 31 as described above, the state in which the base component 11 is inserted into the cylindrical hole of the cover operation component 12 is maintained. Further, the relative position of the cover operating component 12 with respect to the base component 11 can be changed within a range in which the guide protrusion 22 can be displaced along the guide groove 31. In this case, when the guide protrusion 22 is displaced along the straight groove portion 31 a of the guide groove 31, the cover operation component 12 slides in the axial direction with respect to the base component 11. On the other hand, when the guide protrusion 22 is displaced between the straight groove portion 31 a and the retracting groove portion 31 b at the proximal end portion of the guide groove 31, the cover operation component 12 rotates around the axis with respect to the base component 11. . When the guide protrusion 22 enters the retracting groove 31b, the displacement of the cover operating component 12 in the axial direction with respect to the base component 11 is prevented by the contact between the peripheral wall of the retracting groove 31b and the guide protrusion 22. The The state in which the guide protrusion 22 enters the retreat groove 31 b is the initial position of the cover operation component 12 with respect to the base component 11.

  A tubular shaft is fixed to each of the base part 11 and the cover operation part 12 as shown in FIG. More specifically, the cover operating component 12 is provided with a cover shaft 32 as a cover cylinder formed of a polyamide and having a circular cross section. The cover shaft 32 may be formed using other synthetic resin such as polyimide or polyester.

  The cover shaft 32 is formed thinner than the cover operation component 12 and can be inserted into the introduction sheath 50. Further, the cover shaft 32 includes an annular fixing flange 32a that extends outward at the proximal end portion thereof. The fixing flange 32a uses an adhesive or the like in a state where the fixing flange 32a is in contact with the fixing stepped portion 33 formed to reduce the inner diameter on the distal end side of the cover operating component 12 from the proximal end side. By being fixed, the cover shaft 32 is fixed to the cover operating component 12 so as to be on the same axis.

  The position where the fixing step 33 is formed in the cover operation component 12 is on the distal end side of the distal end portion of the guide groove 31, and the cover operation component 12 is displaced with respect to the base component 11. The base part 11 does not interfere with the fixing step 33.

  On the other hand, as shown in FIGS. 2 (a), 3 (b1) and 3 (b2), the base part 11 has a shaft unit having a plurality of tubular shafts 24 and 25 so as to have a plurality of layers in the radial direction. 23 is provided. The shaft unit 23 includes an annular fixing flange 23a that extends outward at a proximal end portion thereof. The fixing flange 23a is fixed using an adhesive or the like in a state where the fixing flange 23a is brought into contact with the fixing stepped portion 21a formed to reduce the inner diameter at the distal end portion of the base part 11 from the proximal end side. Thus, the shaft unit 23 is fixed to the base part 11 so as to be on the same axis.

  As shown in FIG. 2 (b), the shaft unit 23 has a base inserted through the outer shaft 24 so as to be on the same axis as the outer shaft 24 as an extruded member formed thinner than the cover shaft 32. And an inner shaft 25 as a side cylinder. The outer shaft 24 and the inner shaft 25 are formed in a tubular shape having a circular cross section by a synthetic resin such as polyamide. The inner shaft 25 is formed longer than the outer shaft 24, and the inner shaft 25 extends to the distal end side of the outer shaft 24.

  The position of the proximal end portion of the inner shaft 25 in the axial direction is the same position as the proximal end portion of the outer shaft 24, but is not limited to this, and the proximal end of the inner shaft 25 is not limited thereto. The portion may be disposed closer to the proximal side than the proximal end portion of the outer shaft 24, or may be disposed at an intermediate position in the axial direction of the outer shaft 24. In the latter configuration, the inner shaft 25 may be shorter than the outer shaft 24.

  In a state where the cover operation component 12 is integrated with the base component 11, the shaft unit 23 passes through the cylindrical hole of the cover operation component 12 and enters the cover shaft 32. The distal end portion of the outer shaft 24 exists at an intermediate position in the axial direction of the cover shaft 32 regardless of the position in which the cover operation component 12 is disposed with respect to the base component 11. On the other hand, the inner shaft 25 extends further to the distal end side than the cover shaft 32 regardless of the position of the cover operation component 12 with respect to the base component 11.

  In the cover shaft 32, as shown in FIGS. 2A to 2C, a hemostatic member 34 is provided at a position on the distal end side of the outer shaft 24, and the hemostatic member 34 and the outer shaft are provided. A pressing shaft 35 serving as a pressing body is provided between the two and 24.

  The hemostatic member 34 is used to close the puncture site on the blood vessel wall where the introduction sheath 50 is disposed. The hemostatic member 34 is preferably formed of a material having at least one of biocompatibility and bioabsorbability. Specifically, the hemostasis member 34 is formed of a material having high biocompatibility and high bioabsorbability. More specifically, the hemostatic member 34 is formed as a porous (or sponge-like) material using polyethylene glycol (PEG). The hemostatic member 34 is formed by freeze-drying gelled PEG, and swells when placed at the puncture site of the blood vessel wall. The hemostatic member 34 may be formed using gelatin or collagen.

  The pressing shaft 35 is made of polyamide, and is used to press the hemostatic member 34 against the puncture site of the blood vessel wall in a state where the hemostatic member 34 and the pressing shaft 35 are separated from the cover shaft 32. The pressing shaft 35 may be made of polyolefin such as polypropylene or polyethylene, or may be formed using other synthetic resin.

  Each of the hemostatic member 34 and the pressing shaft 35 is formed in a tubular shape having a circular cross section, and its inner diameter is set slightly larger than the outer diameter of the inner shaft 25. Therefore, the inner shaft 25 penetrates the hemostatic member 34 and the pressing shaft 35. Further, the hemostatic member 34 and the pressing shaft 35 are both set so that the outer diameter is substantially the same as or slightly smaller than the inner diameter of the cover shaft 32, and the outer peripheral surface of the hemostatic member 34 and the outer periphery of the pressing shaft 35 are set. The surface is in contact with the inner peripheral surface of the cover shaft 32. Due to the frictional resistance caused by the contact between the outer peripheral surface and the inner peripheral surface, the hemostatic member 34 and the pressing shaft 35 are prevented from being separated from the cover shaft 32 by their own weight, and the pressing shaft is prevented by the force against the frictional resistance. The pressing shaft 35 and the hemostatic member 34 are displaced in a direction in which the pressing shaft 35 and the hemostatic member 34 are separated from the cover shaft 32 by being pressed.

  Here, the process in the case of integrating the cover operation part 12 having the cover shaft 32 with the base part 11 having the shaft unit 23 will be briefly described. First, the shaft unit 23 fixed to the base part 11 is covered. The shaft 32 is inserted. Next, a process of integrating the cover operation component 12 with the base component 11 and fixing the cover shaft 32 to the cover operation component 12 is performed. In this case, the cover operating component 12 includes a pair of forming members so as to bisect the boundary along the direction along the axis, and the guide grooves 31 are formed by combining the pair of forming members. It becomes the composition which will be in a state. Accordingly, the cover component 12 is integrated with the base component 11 such that the base component 11 is sandwiched between the pair of forming members, and the guide protrusions 22 of the base component 11 are inserted into the guide grooves 31. Is done.

(Relationship between base part 11 and stopper operating part 13)
Next, the relationship between the base part 11 and the stopper operating part 13 will be described.

  As shown in FIG. 3 (b 1), a locking groove 26 is formed on the proximal end side of the base cylinder portion 21 in the base part 11 so as to be recessed inward from the outer peripheral surface side. The stopper operating component 13 is supported by the base component 11 using

  As shown in FIGS. 2 (a) and 3 (a2), the stopper operating component 13 has the same inner diameter throughout the axial direction except for the opening portion on the distal end side and the opening portion on the proximal end side. The inner diameter is set to be slightly larger than the outer diameter of the base cylinder portion 21. Further, since the diameter-reduced portion 41 is formed in the opening portion on the proximal end side in the stopper operation component 13, the opening portion on the distal end side has a wider opening. The base part 11 is inserted into the cylindrical hole of the stopper operating part 13 from the opening part on the distal end side. In this case, the base part 11 and the stopper operating part 13 are located on the same axis. A locking projection 42 protruding inward is integrally formed at the opening portion on the distal end side of the stopper operating component 13, and the locking projection 42 enters the locking groove 26 of the base component 11. Yes.

  Specifically, the locking groove 26 and the locking protrusion 42 are formed so as to form a pair with the axis line therebetween. As shown in FIG. 3 (b1), each locking groove 26 is formed from the proximal end of the base part 11 to an intermediate position in the axial direction, and the proximal end of each locking groove 26 is Open to the proximal side. Each locking groove 26 includes a straight groove portion 26a that extends linearly from the proximal end portion toward the distal end side of the base component 11, and a spiral that forms a spiral around the axis from the distal end portion of the straight groove portion 26a. Groove portion 26b, and both groove portions 26a, 26b are continuous. In this case, between the pair of locking grooves 26, the direction in which the spiral groove portion 26b circulates is the same, and the spiral groove portions 26b are formed so as not to interfere with each other.

  A plurality of locking protrusions 42 are formed so as to correspond to the locking grooves 26 on a one-to-one basis, and the pair of locking protrusions 42 are formed at equal intervals around the axis as shown in FIG. ing. The heights and cross-sectional areas of the locking protrusions 42 are set so as to be able to enter the corresponding locking grooves 26 and to be displaced along the locking grooves 26.

  By forming the locking groove 26 and the locking protrusion 42 as described above, the state where the proximal end side of the base part 11 is inserted into the cylindrical hole of the stopper operating part 13 is maintained. Further, the relative position of the stopper operating component 13 with respect to the base component 11 can be changed within a range in which the locking projection 42 can be displaced along the locking groove 26. In this case, when the locking projection 42 is displaced along the straight groove portion 26 a of the locking groove 26, the stopper operating component 13 slides in the axial direction with respect to the base component 11. On the other hand, when the locking projection 42 is displaced along the spiral groove 26b, the stopper operating component 13 rotates about the axis while being displaced in the axial direction with respect to the base component 11.

  As shown in FIG. 2A, a biasing member 43 is provided between the base part 11 and the stopper operating part 13 so as to apply a biasing force toward the proximal side to the stopper operating part 13. It has been. Specifically, a diameter-enlarged stepped portion 27 that integrally faces the opening side of the proximal end side and expands the diameter of the proximal end side is integrally formed on the inner peripheral side of the region where the locking groove 26 is formed in the base part 11. Has been. Moreover, the diameter-reduced part 41 is formed in the opening part of the proximal end side in the stopper operation component 13 as already demonstrated. The reduced diameter portion 41 is formed by integrally forming a column portion 41a that protrudes toward the distal end side and a reduced diameter step portion 41b that is formed in an annular shape at the root portion of the column portion 41a. The reduced diameter step portion 41b faces the enlarged diameter step portion 27 in the axial direction, and an urging member 43 is provided between the step portions 27 and 41b.

  A helical spring is used as the urging member 43, and compression is performed so that the compressed state is maintained even when the stopper operating component 13 is present on the most proximal end side with respect to the base component 11. Is provided. Accordingly, the urging force from the urging member 43 is applied to the base part 11 and the stopper operating part 13 regardless of the position where the stopper operating part 13 is disposed. Accordingly, the stopper operating component 13 can be automatically displaced toward the position closest to the base end 11 with respect to the base component 11, and the state of being arranged at the position closest to the proximal end is shown. It can be held.

  The urging force of the urging member 43 is not only for automatically displacing the stopper operating component 13 to the position closest to the proximal end with respect to the base component 11, but also the stopper operating component 13 is most This also contributes to maintaining the state of being arranged at the position on the distal end side. That is, as shown in FIG. 3 (b1), a wide portion 26c that is wider than the proximal end side is formed at the tip of the spiral groove portion 26b in each locking groove 26. The wide portion 26c is formed by widening the groove width of the spiral groove portion 26b toward the proximal end side, and the corresponding locking protrusion 42 can enter. Since the urging force of the urging member 43 is applied in the direction in which the stopper operating component 13 is displaced toward the proximal end side with respect to the base component 11 as described above, the locking protrusion 42 is formed on the wide portion 26c. When entering, the urging force of the urging member 43 contributes to maintain the state. The state in which the locking protrusion 42 enters the wide portion 26 c is the initial position of the stopper operating component 13 with respect to the base component 11.

  Incidentally, when the locking projection 42 is detached from the wide portion 26c, manual operation of the stopper operating component 13 is required, but the outer peripheral surface of the stopper operating component 13 is shown in FIGS. 1 and 3 (a1). As described above, the outwardly projecting rib 48 is integrally formed to facilitate manual operation.

  As shown in FIGS. 2 (a), 3 (a1), and 3 (a2), a stopper shaft 44 is fixed to the stopper operating component 13 so as to be on the same axis. As shown in FIG. 2D, the stopper shaft 44 includes a wire 45 as a stopper support body made of an elastic metal wire such as nickel titanium alloy or stainless steel. The surface of the wire 45 may be covered with a synthetic resin such as urethane.

  As shown in FIG. 2A, the wire 45 is fixed to a column portion 41 a in the reduced diameter portion 41 of the stopper operating component 13, passes through the cylindrical hole of the base component 11, and further, the inner shaft of the shaft unit 23. The inner shaft 25 extends to the distal end side than the inner shaft 25. In addition, the wire 45 is more distal than the inner shaft 25 in both cases where the overall length of the main unit composed of the base part 11, the cover operating part 12, and the stopper operating part 13 is the shortest and the longest. The state extended to the end side is maintained.

  In the wire 45, a stopper 46 is provided in a region extending to the distal end side of the inner shaft 25 in a state where the stopper operating component 13 is disposed at the initial position. The stopper 46 is formed in a cylindrical shape and a mesh shape using a metal wire formed of a superelastic alloy such as a nickel titanium alloy, and is supported on the wire 45 so as to be on the same axis. Has been.

  In detail, the distal end portion of the stopper 46 is bonded and fixed to the surface of the wire 45 from the outer peripheral side as shown in FIG. 2 (d2). However, the present invention is not limited to this, and the stopper 46 may be welded and fixed to the surface of the wire 45. The fixing ring is configured such that the distal end portion of the stopper 46 is sandwiched in the radial direction together with the wire 45. May be covered.

  On the other hand, the proximal end portion of the stopper 46 is fixed to the distal end portion of the inner shaft 25 as shown in FIG. In this case, the outer peripheral surface of the proximal end portion of the stopper 46 is bonded and fixed to the inner peripheral surface of the inner shaft 25.

  In a situation where the stopper operating component 13 is disposed at the initial position, the distal end portion of the stopper 46 is disposed at a position spaced from the inner shaft 25 toward the distal end side, and the stopper 46 is in an extended state. In this case, the outer diameter of the stopper 46 is the same as or slightly larger than the outer diameter of the inner shaft 25. On the other hand, when the stopper operating component 13 is disposed at the displacement limit position on the proximal end side, the distal end portion of the stopper 46 approaches the distal end portion of the inner shaft 25. Thereby, the stopper 46 will be in a contracted state. The form of the stopper 46 in the contracted state will be described later.

  Here, a process for integrating the stopper operating component 13 having the stopper shaft 44 with the base component 11 having the shaft unit 23 will be briefly described. Since the stopper operating component 13 includes a pair of forming members so as to bisect the direction along the axis, the base component 11 is sandwiched between the pair of forming members, and each of the base components 11 is further separated. The locking projections 42 of the stopper operating component 13 are arranged so as to enter the locking groove 26, and the pair of forming members are fixed. At this time, an urging member 43 in a predetermined compressed state is disposed between the stopper operation component 13 and the base component 11. Next, the wire 45 is inserted through the inner shaft 25 integrated with the base component 11 and the wire 45 is fixed to the column portion 41a of the stopper operating component 13 by bonding or the like. To do. Next, the stopper 46 is fixed to the wire 45 and the inner shaft 25. In this case, the length dimension of the wire 45 is such that each locking projection 42 is disengaged from the corresponding locking groove 26 even when the stopper operating component 13 is disposed at the displacement limit position on the proximal end side. It is set in the range that does not.

  Incidentally, the stopper operating component 13 may be integrated after the cover operating component 12 is integrated with the base component 11, and conversely, the stopper operating component 13 is integrated with the base component 11. The cover operation component 12 may be integrated later. Further, after integrating the cover operating component 12 and the stopper operating component 13 with the base component 11, the hemostatic member 34 and the pressing shaft 35 are inserted into the cover shaft 32. In this case, the inner diameter of the hemostatic member 34 and the inner diameter of the pressing shaft 35 are larger than the outer diameter of the wire 45 and further larger than the outer diameter of the extended stopper 46. Therefore, the wire 45 and the stopper 46 can be inserted into the hemostatic member 34 and the pressing shaft 35.

(Configuration for positioning the hemostatic device 10 on the introduction sheath 50)
Next, a configuration for positioning the hemostatic device 10 having the above configuration on the introduction sheath 50 will be described.

  In the hemostatic device 10, the distal end portion of the main body unit composed of the base component 11, the cover operation component 12, and the stopper operation component 13 is configured by the distal end portion of the cover operation component 12. As shown in FIGS. 3 (c1) and 3 (c2), a positioning portion 36 is formed at the end. The positioning portion 36 can come into contact with a part of the introduction sheath 50 from the proximal end side, and the relative position in the axial direction of the hemostatic device 10 with respect to the introduction sheath 50 is uniquely determined by the contact. It is supposed to be.

  Specifically, as shown in FIG. 1, the introduction sheath 50 includes an introduction shaft 51 formed in a tubular shape with a synthetic resin such as Teflon (registered trademark) resin, and a proximal end of the introduction shaft 51. And a receiving port portion 52 having an opening on the proximal end side that is wider than the lumen of the introduction shaft 51. On the other hand, the positioning portion 36 can insert the proximal end portion of the receiving portion 52 into the inside, and is a positioning projection 53 formed to protrude outward on the outer peripheral surface of the insertion portion of the receiving portion 52. A positioning groove 36a is formed in which can enter. Incidentally, a plurality (specifically, two) of the positioning protrusions 53 are formed so as to be equally spaced around the axis, and a plurality of positioning grooves 36a are also made to correspond to the positioning protrusions 53 on a one-to-one basis. Is formed.

  Each positioning groove 36a is continuous from the opening on the distal end side of the cover operating component 12, and is formed so as to enter from the peripheral edge of the opening toward the proximal end side. Each positioning groove 36a includes a region 36b that enters the periphery of the region continuous from the opening on the distal end side of the cover operating component 12, and the positioning projection 53 enters the region 36b. As a result, the hemostatic device 10 cannot be displaced in the axial direction with respect to the introduction sheath 50. Thereby, the positioning of the hemostatic device 10 with respect to the introduction sheath 50 is completed.

  In a state where the hemostatic device 10 is positioned with respect to the introduction sheath 50, the cover shaft 32 fixed to the cover operation component 12 is distal to the introduction shaft 51 of the introduction sheath 50 as shown in FIG. 1. Will extend to the side. Further, as already described, the inner shaft 25 fixed to the base part 11 and the stopper shaft 44 fixed to the stopper operating part 13 are provided so as to extend further to the distal end side than the cover shaft 32. The inner shaft 25 and the stopper shaft 44 also extend further to the distal end side than the introduction shaft 51, and the stopper 46 also exists on the distal end side.

(Operation method of hemostatic device 10)
Next, an operation method of the hemostatic device 10 will be described with reference to FIG. FIG. 4 is a diagram for explaining an operation method of the hemostatic device 10.

  When the hemostatic device 10 is positioned on the introduction sheath 50, as shown in FIG. 4A, both the cover operation component 12 and the stopper operation component 13 are arranged at the initial position with respect to the base component 11. In the state where the hemostatic device 10 is positioned on the introduction sheath 50, the cover shaft 32, the inner shaft 25, and the stopper shaft 44 extend to the distal end side from the introduction shaft 51 as described above. ing. In this case, the stopper 46 of the stopper shaft 44 is in an extended state, and the outer diameter of the stopper 46 is smaller than the inner diameter of the introduction shaft 51 in the extended state. Therefore, the stopper 46 is prevented from being caught by the introduction shaft 51 when the hemostatic device 10 is positioned with respect to the introduction sheath 50.

  Next, by performing a rotation operation for unlocking the stopper operation component 13, the stopper operation component 13 arranged at the initial position is attached to the biasing member 43 as shown in FIG. The displacement limit position on the proximal end side is reached by the force. In this case, the stopper shaft 44 is also displaced toward the proximal end side. As described above, the stopper 46 is fixed to the wire 45 at the distal end, whereas the proximal end portion is connected to the inner shaft. 25 is fixed. Since the inner shaft 25 is fixed to the base part 11, the stopper 46 is contracted when the stopper operating part 13 reaches the displacement limit position on the proximal end side.

  Here, the contracted state of the stopper 46 will be described with reference to FIGS. 4 (b1) and 4 (b2). When the stopper 46 is contracted, the distal end of the stopper 46 is close to the stopper 46. Since the end portion is approached, the region extending from the distal end portion to the proximal end portion bulges outward, and an annular portion 46 a projecting radially with respect to the wire 45 is generated. The annular portion 46a protrudes outward from the cover shaft 32 and the introduction shaft 51. Furthermore, the distance between any two points facing each other across the axis on the outer peripheral portion of the annular portion 46a is determined by the introduction sheath 50. It becomes larger than the hole diameter of the puncture site of the blood vessel wall to be arranged. As a result, the annular portion 46a can be hooked on the blood vessel wall from the inside of the blood vessel.

  Further, when the stopper 46 transitions from the extended state to the contracted state, the locking protrusion 42 of the stopper operating component 13 needs to be displaced along the spiral groove 26b in the locking groove 26 of the base component 11, The stopper operating component 13 rotates around the axis, and the wire 45 rotates accordingly. Accordingly, the stopper 46 does not rotate around the axis during the above transition, but the distal end rotates around the axis. As a result, the annular portion 46a of the stopper 46 is shown in FIG. 4 (b2). Thus, the mesh-shaped cylinder is not only simply contracted, but is also twisted around the axis. Therefore, the strength of the annular portion 46a is increased, and deformation of the annular portion 46a when the annular portion 46a is hooked on the blood vessel wall is suitably suppressed.

  Next, an operation of pulling the cover operation component 12 closer to the proximal end than the initial position is performed. In the operation, first, the base component 11 is rotated to displace the guide protrusion 22 of the base component 11 from the retracting groove 31b in the guide groove 31 of the cover operating component 12 to the straight groove 31a. In this case, the reason why the base part 11 is rotated instead of the cover operating part 12 is to prevent the introduction sheath 50 in contact with the stenosis portion of the patient from being rotated.

  Further, the rotation direction is opposite to the rotation direction of the stopper operation component 13 when the stopper operation component 13 is disposed at the displacement limit position on the proximal end side. In other words, the retraction groove 31b of the guide groove 31 has a rotation direction of the base component 11 for displacing the guide protrusion 22 from the retraction groove 31b to the straight groove 31a to displace the stopper operation component 13 from the initial position. The stopper operating component 13 is formed in the direction opposite to the rotation direction. Accordingly, when the rotation operation for unlocking the stopper operation component 13 is performed, the relative position of the cover operation component 12 with respect to the base component 11 is suppressed from being displaced from the initial position.

  Incidentally, when positioning the hemostatic device 10 with respect to the introduction sheath 50, the hemostatic device 10 is rotated in order to integrate the hemostatic device 10 with the introduction sheath 50. The direction is the same as the rotation direction of the stopper operating component 13 when the rotation operation for unlocking is performed. However, the present invention is not limited to this, and the positioning groove 36a may be formed so as to be opposite to the rotation direction of the stopper operating component 13.

  After rotating the base part 11 to displace the guide protrusion 22 from the retracting groove part 31b of the guide groove 31 to the straight groove part 31a, an operation of pulling the cover operating part 12 to the proximal end side with respect to the base part 11 is performed. By doing so, the guide projection 22 is displaced along the straight groove portion 31a, and the cover operation component 12 is disposed at the displacement limit position on the proximal end side as shown in FIG. 4C. In addition, the introduction sheath 50 fixed to the cover operation component 12 is also displaced to the proximal end side following that.

  In this case, the cover shaft 32 fixed to the cover operating part 12 follows the cover operating part 12 and is displaced to the proximal end side, while the shaft unit 23 fixed to the base part 11 follows the displacement. do not do. Then, even if the pressing shaft 35 and the hemostatic member 34 follow the cover shaft 32 and attempt to displace to the proximal end side, it is impossible due to contact with the outer shaft 24 of the shaft unit 23 from the distal end side. It becomes. When the cover operation component 12 is disposed at the displacement limit position on the proximal end side, the entire hemostatic member 34 is exposed from the cover shaft 32, and the distal end side of the pressing shaft 35 is also covered by the cover shaft 32. The length dimensions of the cover shaft 32, the pressing shaft 35, and the outer shaft 24 are set so as to be exposed from the above.

  Next, the cover operating component 12 is moved closer to the base component 11 by performing an operation of returning the stopper operating component 13 from the displacement limit position on the proximal end side to the initial position, as shown in FIG. On the other hand, the stopper operating component 13 is disposed at the initial position while being disposed at the displacement limit position on the distal end side. In this case, since the entire locking groove 26 is formed so as not to be covered by the cover operating component 12 disposed at the displacement limit position on the proximal end side, the transition to the above state and the above state is made. In this process, the cover operating component 12 and the stopper operating component 13 do not interfere with each other.

  In this state, the stopper 46 transitions from the contracted state to the extended state. Therefore, in order to place the pressing shaft 35 and the hemostatic member 34 in place, the stopper 46 can pass through the cylindrical holes of the hemostatic member 34 and the pressing shaft 35 when performing the separation operation of the hemostatic device 10 excluding these members. Thus, the stopper 46 is not caught during the separation operation.

(Hemostasis method using the hemostasis device 10)
Next, a hemostasis method using the hemostasis device 10 will be described with reference to FIGS. 5 and 6. 5 and 6 are diagrams for explaining a hemostasis method using the hemostasis device 10.

  The state shown in FIG. 5A is a state in which the introduction sheath 50 is disposed at the puncture site formed from the patient's skin to the blood vessel after completion of the treatment using a medical instrument such as a catheter. As shown in FIG. 5B, the hemostatic device 10 is positioned from the proximal end side with respect to the introduction sheath 50 in this state, and the hemostatic device 10 is integrated with the introduction sheath 50. When the hemostatic device 10 is integrated with the introduction sheath 50, the cover shaft 32, the inner shaft 25, and the stopper shaft 44 extend to the distal end side of the introduction sheath 50, and these are naturally Placed in a blood vessel.

  Thereafter, by performing a rotation operation for unlocking the stopper operating component 13, the stopper operating component 13 is arranged at the displacement limit position on the proximal end side as shown in FIG. The stopper 46 is in a contracted state. Thereafter, as shown in FIG. 5D, the introduction sheath 50 in which the hemostatic device 10 is integrated until the stopper 46 is hooked from the inside of the blood vessel to the peripheral portion of the hole portion at the puncture site of the blood vessel wall. Pull toward the proximal end.

  Thereafter, the cover operating component 12 is arranged at the displacement limit position on the proximal end side while continuing the pulled state. As a result, as shown in FIG. 6A, the introduction shaft 51 and the cover shaft 32 are pulled out of the living body, and the hemostatic member 34 and the pressing shaft 35 are exposed from the cover shaft 32. In this case, the hemostatic member 34 is disposed in the tissue between the blood vessel and the skin. Further, the pressing shaft 35 has a distal end portion disposed in the tissue, and a part of the pressing shaft 35 protrudes outside the tissue.

  In this state, the hemostatic member 34 is pressed from the outside of the blood vessel to the hole portion in the puncture site of the blood vessel wall by pressing the region protruding from the tissue of the pressing shaft 35 to the blood vessel side. In this case, since the pulled state is continued, the state where the stopper 46 is caught inside the blood vessel is maintained. Therefore, when the hemostatic member 34 is pressed, the blood vessel is less likely to be bent inward, and the hemostatic member 34 can be favorably pressed against the hole portion at the puncture site of the blood vessel wall. And in the state pressed in this way, the hemostatic member 34 will swell and the hemostatic member 34 will remain in the position pressed against the hole part in a puncture location.

  Thereafter, the stopper operation component 13 is returned to the initial position, so that the stopper 46 is extended as shown in FIG. 6B. Then, the hemostatic device 10 in which the introduction sheath 50 is integrated is pulled out. At this time, the hemostatic device 10 is pulled out with the pressing shaft 35 pressed against the hemostatic member 34 side. As a result, as shown in FIG. 6C, the hemostatic member 34 and the pressing shaft 35 remain. Thereafter, by pulling out the pressing shaft 35, as shown in FIG. 6D, only the hemostatic member 34 remains.

  According to the embodiment described in detail above, the following excellent effects are obtained.

  When hemostasis is performed at the place where the introduction sheath 50 is disposed, the hemostatic device 10 is disposed at the position where the introduction sheath 50 is disposed, and the hemostasis member 34 is attached to the outside of the introduction sheath 50 using the outer shaft 24 corresponding to the pushing member. Can be left in place. Further, since the stopper 46 is provided, it is possible to perform a hemostasis operation with the hemostasis device 10 hooked, and the workability of the operation is improved. Further, when the hemostatic member 34 is pressed against the blood vessel wall to be stopped, the displacement of the blood vessel wall into the blood vessel can be restricted by the stopper 46, and the hemostatic member 34 is easily pressed.

  In this configuration, the hemostatic device 10 is positioned with respect to the introduction sheath 50 using the positioning portion 36, so that the stretched stopper 46 is naturally arranged on the distal side of the introduction sheath 50. . Thereby, when starting the hemostasis operation using the hemostasis device 10, it is not necessary to adjust the amount of insertion of the hemostasis device 10 into the blood vessel, and the workability of the placement operation of the hemostasis device 10 is improved.

  In addition, since the stopper 46 is provided so as to be disposed at a position distal to the cover shaft 32, the stopper 46 initially disposed in the cover shaft 32 is disposed further to the distal side than the cover shaft 32. Compared to the configuration in which the mechanism for displacing the position is provided, it is possible to achieve the excellent effects as described above while simplifying the configuration.

  Moreover, in the technique described in Japanese translations of PCT publication No. 2008-518743, when the hooking member equivalent to the stopper shaft 44 of the hemostatic device 10 is hooked on the inner wall of the blood vessel, both the introduction sheath and the hooking member are used. Or after pulling only the hooking member, the introduction sheath needs to be pulled along the hooking member. On the other hand, in the case of the hemostatic device 10, the stopper 46 of the stopper shaft 44 can be obtained by simply pulling one of the introduction sheath 50 and the hemostatic device 10 without causing the introduction sheath 50 and the hemostatic device 10 to interfere with each other. Can be hooked on the inner wall of the blood vessel. That is, according to this configuration, the work procedure can be facilitated. In addition, it is possible to suppress breakage of the hemostatic device 10 due to interference between the hemostatic device 10 and the introduction sheath 50.

  Moreover, if it is this hemostatic instrument 10, compared with the instrument described in the said special table 2008-518743 gazette, it becomes possible to shorten a full length. That is, in the prior art, since the tip of the hooking member is not positioned, it is necessary to increase the amount of insertion in order to carefully insert the hooking member into the blood vessel. On the other hand, in the present hemostatic device 10, since the position of the stopper 46 is determined, the length dimension of the stopper shaft 44 can be minimized, and accordingly, the overall length of the hemostatic device 10 is increased. It can be shortened.

  Since the transition between the extended state and the contracted state of the stopper 46 is performed by displacing the stopper operating component 13 with respect to the base component 11, a configuration in which fluid circulation is required for the transition. The configuration can be simplified compared to the above. Further, since the stopper operation component 13 need only be operated so as to change the relative position with respect to the base component 11 at the time of the transition, the operability of the operation is improved. Furthermore, when the hemostatic member 34 is exposed, it is only necessary to operate the cover operation component 12 so as to change the relative position with respect to the base component 11, so that the operability of the operation is improved.

  The base component 11 is provided with an inner shaft 25 so as to be interposed between the hemostatic member 34 and the wire 45 in the cover shaft 32. Thereby, the influence of the displacement of the wire 45 when the stopper 46 is transitioned between the extended state and the contracted state is received by the inner shaft 25 so that the influence of the displacement does not reach the hemostatic member 34. Is possible. Therefore, it is possible to prevent the hemostatic member 34 from being displaced in the axial direction when the stopper 46 is moved.

  Further, since the proximal end portion of the stopper 46 is supported by the inner shaft 25, the stopper 46 expands and contracts when the wire 45 is displaced in the axial direction. As a result, the inner shaft 25 can be used to extend and contract the stopper 46 in the axial direction, and the configuration can be simplified as the inner shaft 25 is multi-functionalized.

  When the stopper 46 is in the contracted state, the stopper 46 is twisted around the axis, so that the locking force of the stopper 46 with respect to the blood vessel wall in the contracted state can be increased. However, in this configuration, not only a force for displacing the stopper operating component 13 toward the proximal side but also a force for twisting the stopper 46 around the axis is required when the stopper 46 is in the contracted state. On the other hand, even if it is set as the structure which produces the above twist by providing the biasing member 43 which biases the stopper operating component 13 toward the proximal side, the stopper operating component 13 is The operability when displaced toward the proximal side is improved.

  The present invention is not limited to the description of the above embodiment, and may be implemented as follows, for example.

  (1) In the configuration for positioning the hemostatic device 10 with respect to the introduction sheath 50, the positioning projection 53 formed on the introduction sheath 50 is engaged with the positioning groove 36a formed on the hemostasis device 10. For example, a positioning groove may be formed in the introduction sheath 50 and a positioning protrusion may be formed in the hemostatic device 10. Further, in the state where the positioning unit is positioned, the movement of both the distal side and the proximal side of the hemostatic device 10 with respect to the introduction sheath 50 is not limited to the configuration. A wall portion that abuts from the proximal end side is provided as a positioning portion with respect to the peripheral edge portion of the opening on the distal end side, and in the positioned state, movement of the hemostatic device 10 on the distal side relative to the introduction sheath 50 is restricted, and It is good also as a structure by which the movement of a side is not controlled. The positioning may be performed by attaching another member for positioning the hemostatic device 10 to the introduction sheath 50, and the hemostatic device 10 is connected to the introduction sheath 50 by the separate member. It is good also as a structure made to integrate.

  (2) The stopper is not limited to the stopper 46 of the above-described embodiment that expands and contracts in the axial direction, and may be a balloon that expands or contracts when fluid flows. In this case, as shown in another embodiment of the hemostatic device 60 in FIG. 7, a fluid injection hub 61 may be provided in place of the stopper operating component 13, and the fluid may be circulated through the injection hub 61. . When a fluid is supplied through the infusion hub 61, the balloon 62 is inflated as shown by a two-dot chain line in FIG. 7, and the balloon 62 is contracted by applying a negative pressure to discharge the fluid. Even in this configuration, the hemostatic device 60 is positioned with respect to the introduction sheath 50 using the positioning portion 36, so that the deflated balloon 62 is naturally arranged on the distal side of the introduction sheath 50. It becomes a state. Thereby, when starting the hemostatic operation using the hemostatic device 60, the operation of adjusting the insertion amount of the hemostatic device 60 into the blood vessel is not necessary, and the workability of the arrangement operation of the hemostatic device 60 is improved. In addition, in FIG. 7, the same number is attached | subjected about the same structure as the said hemostatic device 10. In FIG.

  (3) In a configuration in which a balloon is provided as a stopper, a state in which fluid is supplied toward the balloon by manually operating the stopper operating component 13 so as to be displaced with respect to the base component 11, and fluid from the balloon It is good also as a structure switched to the state discharged | emitted. Further, the stopper may be a tip of the wire 45, and by manually operating the stopper operating component 13, the tip may be deformed between an extended state and a folded state.

  (4) The stopper operating component 13 is not limited to the configuration accompanied by the displacement in the axial direction when the state of the stopper 46 is changed. For example, the winding of the wire 45 with the rotation operation of the stopper operating component 13 Alternatively, when the state of the stopper 46 is changed, the stopper operation component 13 may be configured so that only the rotation operation around the axis is performed. Further, instead of this configuration, when the state of the stopper 46 is changed, a configuration in which only a sliding operation in the axial direction is required without requiring any rotation operation of the stopper operating component 13 may be adopted. Instead of this configuration, when the stopper operating component 13 is displaced between the initial position and the position on the proximal end side, the stopper operating component 13 may be configured to be displaced helically over the entire displacement range. Note that a configuration that requires only such a rotation operation, a configuration that requires only a slide operation, or a configuration that displaces spirally may be applied to the cover operation component 12.

  (5) The biasing member 43 may be provided so as to bias the stopper operating component 13 toward the initial position. Further, the biasing member 43 may be omitted.

  (6) The stopper 46 may be already twisted around the axis in the extended state. Even in this case, by making the wire 45 rotate around the axis when the stopper 46 is changed to the contracted state, the stopper 46 is more twisted around the axis in the contracted state than in the extended state.

  (7) The stopper 46 is configured such that the distal end portion is displaced toward the proximal end side when the stopper 46 transitions from the expanded / contracted state to the contracted state, but this may be reversed. In addition, the stopper operating component 13 may be provided in a knock pen type that requires a pressing operation of a predetermined part regardless of whether the stopper 46 is in the contracted state or the stopper 46 is returned to the extended state.

(Other inventions extracted from the above embodiment)
Other inventions extracted from the above embodiment are shown below.

First another hemostatic device: a hemostatic device for performing hemostasis at the place where the introduction cylinder is disposed after performing the treatment with the introduction cylinder disposed through the tissue,
A cover cylinder having a cylindrical hole that can be inserted through the introduction cylinder and can accommodate a hemostatic member placed in the tissue in order to stop hemostasis at the placement location;
A blood vessel wall provided at a position distal to the cover cylinder so as to be disposed on the distal side of the distal end portion of the introduction cylinder, and introducing the introduction cylinder. A stopper formed so as to be able to transition to each state of a locked state in which the peripheral wall of the opening comes into contact with the peripheral wall of the opening and can be locked to the blood vessel wall, and a non-locked state to avoid the contact;
A stopper support body which is provided so as to pass through the cylindrical hole of the cover cylinder and has the stopper at a position extending more distally than the cover cylinder;
The cover cylinder is provided so as to be supported at a proximal end side with respect to the support target in which the cover cylinder is integrated, and more proximal than the cover cylinder. A stopper operation that supports a portion that is closer to the proximal end side and that is displaceable with respect to the support target and that causes the stopper to transition between the locked state and the non-locked state through the displacement. Parts,
With
The stopper transitions between the locked state and the non-locked state by expanding and contracting in the axial direction, and a part of the stopper is supported by the stopper support body. Is supported on the side that does not follow when the stopper support is displaced,
The stopper operating component is provided so as to rotate around an axis in the process of displacing the stopper from the initial position where the stopper is in the unlocked state to the locking position where the stopper is in the locked state.
When the stopper operating component is displaced from the initial position to the locking position, the rotational force around the axis of the stopper operating component is transmitted to the stopper through the stopper support, so that the stopper is It is characterized by being twisted around an axis.

  According to this configuration, when hemostasis is performed at an arrangement location of the introduction cylinder, the hemostasis device may be arranged at the arrangement location and the hemostasis member may be placed outside the introduction cylinder. Further, since the stopper is provided, it is possible to perform an operation for hemostasis while the hemostasis device is hooked, and the workability of the operation is improved. In addition, since the stopper is twisted around the axis when the stopper is in the locked state, it can increase the locking force of the stopper in the locked state. Further, since the locking force is naturally increased by changing the stopper from the non-locking state to the locking state, the operability is not lowered when the locking force is increased.

Second another hemostasis device: a hemostasis device for performing hemostasis of the placement location of the introduction cylinder after performing the treatment with the introduction cylinder disposed through the tissue,
A cover cylinder having a cylindrical hole that can be inserted through the introduction cylinder and can accommodate a hemostatic member placed in the tissue in order to stop hemostasis at the placement location;
A blood vessel wall provided at a position distal to the cover cylinder so as to be disposed on the distal side of the distal end portion of the introduction cylinder, and introducing the introduction cylinder. It is possible to transition to each of a locked state in which the peripheral wall of the opening comes into contact with the blood vessel wall and can be locked to the blood vessel wall, and a non-locked state in which the contact is avoided. A stopper made by expansion and contraction in the axial direction of
A stopper support body which is provided so as to pass through the cylindrical hole of the cover cylinder and has the stopper at a position extending more distally than the cover cylinder;
The cover cylinder is provided so as to be supported at a proximal end side with respect to the support target in which the cover cylinder is integrated, and more proximal than the cover cylinder. A stopper operation that supports a portion that is closer to the proximal end side and that is displaceable with respect to the support target and that causes the stopper to transition between the locked state and the non-locked state through the displacement. Parts,
The stopper cylinder is provided so as to be interposed between the hemostatic member and the stopper support in the cylindrical hole of the cover cylinder, and is integrated with the support target, thereby An intermediate body provided so as not to follow the displacement of the stopper support body accompanying the displacement;
It is characterized by having.

  According to this configuration, when hemostasis is performed at an arrangement location of the introduction cylinder, the hemostasis device may be arranged at the arrangement location and the hemostasis member may be placed outside the introduction cylinder. Further, since the stopper is provided, it is possible to perform an operation for hemostasis while the hemostasis device is hooked, and the workability of the operation is improved. Further, the influence of the displacement of the stopper support when the stopper is changed is received by the intervening body, so that the influence of the displacement does not reach the hemostatic member. Thereby, it is possible to prevent the hemostatic member from being displaced in the axial direction when the stopper is moved.

  When attention is paid to the effect of the first another hemostatic device or the second other hemostatic device, a positioning portion for positioning the hemostatic device 10 with respect to the introduction sheath 50 is not essential. It is good also as a structure which needs to adjust the insertion amount of the hemostatic device 10 so that the stopper 46 may be arrange | positioned in the blood vessel at the time of the start of the hemostatic operation | work by the hemostatic device 10. FIG. Further, when the hemostatic device 10 is positioned with respect to the introduction sheath 50, an actuator may be provided that receives a predetermined driving force to displace the stopper 46 into the blood vessel.

  DESCRIPTION OF SYMBOLS 10 ... Hemostatic instrument, 11 ... Base part, 12 ... Cover operation part, 13 ... Stopper operation part, 24 ... Outer shaft, 25 ... Inner shaft, 32 ... Cover shaft, 34 ... Hemostasis member, 35 ... Shaft for pressing, 36 ... Positioning part, 43 ... biasing member, 44 ... shaft for stopper, 45 ... wire, 46 ... stopper, 50 ... sheath for introduction.

Claims (12)

After performing the treatment in a state where the introduction cylinder is disposed through the tissue, the hemostasis device for hemostasis of the placement location of the introduction cylinder,
A cover cylinder having a cylindrical hole that can be inserted through the introduction cylinder and can accommodate a hemostatic member placed in the tissue in order to stop hemostasis at the placement location;
A base component provided on the proximal side with respect to the cover cylinder;
A cover operating component fixed to the proximal side of the cover cylinder and provided so as to be axially displaceable with respect to the base component;
A shaft unit fixed to the base part and inserted into the cylindrical hole of the cover cylinder;
A stopper fixed to the shaft unit;
A positioning portion provided in the cover operating component;
With
The range of displacement of the cover operating part relative to the base part is the initial stage in which the hemostatic member is accommodated in the cylindrical hole of the cover cylinder and displacement of the cover operating part relative to the base part in the axial direction is prevented. And a discharge position for discharging the hemostatic member from the opening on the distal end side of the cover cylinder to the outside of the cover cylinder,
The stopper is provided at a position distal to the cover cylinder so that the stopper can be disposed distal to the distal end of the introduction cylinder, and the introduction cylinder is introduced. It is formed so as to be able to transition to each of a locked state in which it can be brought into contact with the peripheral wall of the opening of the blood vessel wall from within the blood vessel and locked to the blood vessel wall, and a non-locked state in which the contact is avoided. And
The positioning portion is capable of positioning the hemostatic device relative to the introduction cylinder by contacting a part of the introduction cylinder, and the relative position of the cover operation component with respect to the base component When the positioning is performed in a state in which the stopper is in the initial position, the stopper in the unlocked state is arranged on the distal side of the distal end portion of the introduction cylinder. A hemostatic device characterized by that. A stopper support body which is provided so as to pass through the cylindrical hole of the cover cylinder and has the stopper at a position extending more distally than the cover cylinder;
Present in the proximal end than the cover accommodating cylinder in the support member for the stopper with are provided so as to be supported also by the proximal end side of the cover accommodating cylinder relative to said base component A stopper operating component that supports a portion and is displaceable with respect to the base component and causes the stopper to transition between the locked state and the non-locked state through the displacement;
The hemostatic device according to claim 1, comprising: The stopper transitions between the locked state and the unlocked state by expanding and contracting in the axial direction.
The displacement range of the stopper operating component includes an initial position where the stopper is in the non-locking state and a locking position where the stopper is in the locking state. 2. The hemostatic device according to 2. An intermediate body provided so as to be interposed between the hemostatic member and the stopper support in the cylindrical hole of the cover cylinder;
The said interposition body consists of a part of said shaft unit fixed to the said base component so that it may not follow the displacement of the said support body for stopper accompanying the displacement of the said stopper operation component. Hemostatic device. A part of the stopper is supported by the stopper support body, and the other part is supported by the interposition body. When the stopper operation part is displaced with respect to the base part , The hemostatic device according to claim 4, wherein the device is expanded and contracted in an axial direction to transition between the locked state and the unlocked state. A part of the stopper is supported by the stopper support, and the other part is supported on the side that does not follow the displacement of the stopper support.
The stopper operating component is provided to rotate around an axis in the process of being displaced from the initial position to the locking position.
When the stopper operating component is displaced from the initial position to the locking position, the rotational force around the axis of the stopper operating component is transmitted to the stopper through the stopper support, so that the stopper is The hemostatic device according to any one of claims 3 to 5, wherein the hemostatic device is twisted around an axis.   The hemostatic device according to any one of claims 3 to 6, further comprising a biasing unit that biases the stopper operating component to one of the initial position and the locking position. In the tube hole of the cover cylinder, it is provided so as to be movable in the axial direction, and comes into contact with the hemostasis member from the proximal end side so that the hemostasis member is located at the distal end side of the cover cylinder An extrusion member that is discharged from the opening to the outside of the cover cylinder,
The pushing member is composed of a part of the shaft unit fixed to the base part,
The hemostatic device according to any one of claims 2 to 7, wherein the stopper operating component is supported by the base component. The relative position of the stopper operating part with respect to the base part includes an initial position where the stopper is in the non-locking state and a locking position where the stopper is in the locking state,
The cover operating part is positioned relative to the base part at an initial position in which the hemostatic member is accommodated in the cylindrical hole of the cover cylinder, and the hemostatic member is moved by the action of the pushing member. And a discharge position for discharging to the outside,
The stopper operating part needs to be rotated in a specific direction around the axis when the stopper operating part is operated to start displacement from the initial position toward the locking position. Is formed,
The cover operation part rotates the base part in a direction opposite to the specific direction when the base part is operated to start displacement of the cover operation part from the initial position toward the discharge position. The hemostatic device according to claim 8, wherein the hemostatic device is formed as necessary.   The hemostatic device according to claim 1, wherein the stopper is a balloon that expands when a fluid is supplied and contracts when the fluid is discharged.   The hemostatic device according to any one of claims 1 to 10, wherein the positioning portion includes a portion that generates an engagement relationship with the introduction cylinder. In the cover cylinder, a pressing body is provided closer to the proximal end side than the hemostatic member,
The hemostatic member and the pressing body are discharged from the opening on the distal end side of the cover cylinder to the outside of the cover cylinder when the cover cylinder is displaced toward the proximal end side. The hemostatic device according to any one of claims 1 to 11, wherein the hemostatic device is provided so as to be separable from the hemostatic device in the discharged state.

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