JP2010011981A - In vivo tissue closing device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an in vivo tissue closing device for easily and reliably closing an open wound formed on an in vivo tissue membrane. <P>SOLUTION: A clip 4 includes a clip body 40 and a thread 46. The clip body 40 includes a seal part 41, a deformable deformation part 42, and a connection part 44 for connecting the seal part 41 and the transformable deformation part 42 and going through the open wound. Swelling parts 47 are provided respectively so as to cover outer surfaces on a surface and side face on the deformation part 42 side of the seal part 41, an opposite surface to the seal part 41 of the deformation part 42 when the deformation part 42 is in a second shape, and a side face of a part corresponding to the opposite face. Each of the swelling parts 47 comprise a swelling material which is in contact with liquid and absorbs the liquid to swell. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an in vivo tissue closure device.

  Conventionally, minimally invasive surgery performed by inserting a diagnostic or therapeutic device such as a catheter into a blood vessel or other in vivo tissue has been widely performed. For example, in the treatment of stenosis of the coronary artery of the heart, it is necessary to insert a device such as a catheter into the blood vessel in order to perform the treatment.

  Such insertion of a catheter into a blood vessel is usually performed through a puncture hole formed in the thigh. Therefore, it is necessary to stop hemostasis of the puncture hole after the therapeutic treatment is completed, but since the blood pressure at the time of bleeding from the femoral artery (bleeding blood pressure) is high, the medical worker keeps pressing with fingers for a long time ( Such as manual compression) is required.

  In recent years, in order to perform such hemostasis work easily and reliably, various devices have been developed that close holes formed in a blood vessel (a wound penetrating a blood vessel wall) by being inserted through the wound (for example, Patent Document 1).

  The in-vivo tissue closure device described in Patent Document 1 includes a plate-shaped seal portion that covers a wound hole and a peripheral portion of the wound hole from one surface side of the in-vivo tissue membrane, and is substantially perpendicular to the seal portion. A first configuration that extends in a direction and contracts in a direction substantially parallel to the seal portion, and a second configuration that contracts in a direction approximately perpendicular to the seal portion and expands in a direction approximately parallel to the seal portion A deformable portion having a frame shape that can be deformed between and a thread-like body that holds the deformed portion in a predetermined form between the first form and the second form. Have. In this in-vivo tissue closure device, the deformed portion covers the wound hole and the peripheral portion of the wound from the outside of the blood vessel wall, and the seal portion covers the wound hole and the peripheral portion of the wound from the inside of the blood vessel wall. The blood vessel wall is sandwiched between the deformed portion and the wound hole is closed.

  In the in-vivo tissue closure device of Patent Document 1, it is preferable that the sealing portion and the deforming portion are large from the viewpoint of improving hemostasis, and from the viewpoint of smoothly performing the hemostasis operation, the sealing portion and the deforming portion are preferable. The parts are preferably small and these are contradictory.

  That is, in the in-vivo tissue closure device of Patent Document 1, if the seal part or the deformed part is enlarged, the seal part or the deformed part is likely to be caught on the blood vessel wall at an unfavorable place in the blood vessel at the time of hemostasis. . In addition, if the seal part or the deformed part is made small, the hemostatic property is lowered, and the seal part may come out of the blood vessel from the wound hole.

  Furthermore, the hemostatic effect may be affected by the thickness (thickness) and state of the patient's blood vessel, the state of the tissue surrounding the blood vessel, and the like.

JP 2006-167711 A

  An object of the present invention is to provide an in vivo tissue closure device capable of easily and reliably closing a wound formed in an in vivo tissue membrane.

Such an object is achieved by the present inventions (1) to (20) below.
(1) A biological tissue closure device for closing a wound penetrating a biological tissue membrane,
A plate-like seal portion covering the wound hole and the peripheral portion of the wound hole from one surface side of the in vivo tissue membrane;
A deformable portion that can be deformed into a shape that sandwiches the wound with the seal portion from the other surface side of the in vivo tissue membrane;
Holding means for holding the deforming portion in the shape;
A biological tissue closure device, wherein a swelling portion made of a material that swells in contact with a liquid is provided on at least a part of the outer surface of the biological tissue closure device.

  (2) The in-vivo tissue closure device according to (1), wherein the swelling portion is provided in at least one of the seal portion and the deformation portion.

  (3) The in-vivo tissue closure device according to (1) or (2), wherein the swelling portion is provided on a surface and a side surface of the seal portion on the deformation portion side.

  (4) The deforming portion extends in a direction substantially perpendicular to the seal portion, and is reduced in a direction substantially parallel to the seal portion, and a direction substantially perpendicular to the seal portion. The living body according to any one of the above (1) to (3), which has a frame shape that contracts to a second shape expanded in a direction substantially parallel to the seal portion. Tissue closure.

  (5) The swelling portion is provided on a surface of the deformation portion facing the seal portion when the deformation portion has the second shape and on a side surface corresponding to the facing surface (4) ) Tissue closure device in vivo.

  (6) The in vivo tissue closure device according to any one of (1) to (5), wherein the deformable portion has a pantograph-like shape.

  (7) The above-mentioned (1) to (6), which has a connecting portion that connects the seal portion and the deformable portion and passes through the flaw, and the swelling portion is not provided on the outer surface of the connecting portion. ) In vivo tissue closure device.

  (8) The in-vivo tissue closure device according to any one of (1) to (7), wherein the swelling portion is obtained by applying and drying a solution containing a material constituting the swelling portion.

  (9) The surface of the part forming the swollen part of the tissue closure device in the living body is higher in hydrophilicity than the surface of the part not forming the swollen part. The in-vivo tissue closure device described.

  (10) The in vivo tissue closure device according to any one of the above (1) to (9), wherein at least a surface of a part forming the swelling portion of the in vivo tissue closure device is subjected to a hydrophilic treatment.

  (11) The in-vivo tissue closure device according to any one of (1) to (10), wherein a surface of at least a portion forming the swelling portion of the in-vivo tissue closure device is subjected to a roughening treatment. .

  (12) The in-vivo tissue closure device according to any one of (1) to (11), wherein the swelling portion is made of a gel polymer.

  (13) The in vivo living body according to (12), wherein the gel polymer has an anionic group in a part of its molecular structure and swells upon contact with a liquid that deprotonates the anionic group. Tissue closure.

  (14) The in vivo tissue according to (12), wherein the gel polymer has a cationic group in a part of its molecular structure and swells by contact with a liquid that protonates the cationic group. Closure.

  (15) The in vivo tissue closure device according to any one of (12) to (14), wherein the gel polymer includes at least one selected from acrylic acid, methacrylic acid and derivatives thereof as a monomer component. .

  (16) The in-vivo tissue closure device according to any one of (12) to (15), wherein the gel polymer includes an ethylenically unsaturated compound as a crosslinking agent.

  (17) The in vivo tissue closure device according to any one of (12) to (16), wherein the gel polymer is swollen by contact with a liquid having a pH of 7.1 to 7.8.

  (18) The tissue closure device according to any one of (12) to (16), wherein the gel polymer swells by contact with blood and body fluid around the wound.

  (19) The in-vivo tissue closure device according to any one of (12) to (18), wherein the gel polymer swells so that its volume is 3 to 5 times.

  (20) The in-vivo tissue closure device according to any one of (1) to (19), wherein each of the seal portion and the deformable portion is made of a bioabsorbable material.

  According to the present invention, since the swollen part swells, the in-vivo tissue closure device becomes larger, so that the closing property of the wound formed in the in-vivo tissue film such as the blood vessel wall is improved, and the wound is surely secured. Can be closed (closed) and completely hemostatic. It is also possible to prevent the seal portion from coming out of the wound hole.

  In addition, the work can be easily and smoothly performed by closing the wound with the tissue closing tool in the body before the swelling part swells being small.

  Hereinafter, the in-vivo tissue closure device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  1 is a perspective view showing an embodiment of a biological tissue closing device, FIG. 2 is an exploded perspective view of the placement device of the biological tissue closing device shown in FIG. 1 (showing each member (part)), FIG. FIG. 4 is a perspective view showing an embodiment of the in-vivo tissue closing device of the present invention provided in the in-vivo tissue closing device shown in FIG. 1, and FIG. 4 is an explanation showing an example of a knot of the in-vivo tissue closing device shown in FIG. 5 is an explanatory view showing another example of the knot of the in-vivo tissue closure shown in FIG. 3, and FIG. 6 is a cross-sectional view of the clip body of the in-vivo tissue closure shown in FIG. FIG. 7 is a cross-sectional view taken along line B-B of FIG. 3 of the clip body of the in-vivo tissue closure device shown in FIG. 3, and FIG. 8 is a cross-sectional view of the in-vivo tissue closure device shown in FIG. It is sectional drawing in the CC line | wire in FIG. 3 of a clip main body. Moreover, FIG. 9 is a figure which shows the thread | yarn support part, pin, and thread | yarn of the in-vivo tissue closure apparatus shown in FIG. 1, FIG. 9 (a) is a perspective view, FIG.9 (b) shows typically. FIG. 10 is a cross-sectional view showing a base portion of the first charge member of the in-vivo tissue closing apparatus shown in FIG. 1, FIG. 11 is a perspective view showing a holding member of the in-vivo tissue closing apparatus shown in FIG. FIG. 13 is a perspective view showing a base end side member and a tip end side member of the holding member shown in FIG. 11, and FIG. 13 is a cross-sectional view showing the holding member shown in FIG. FIGS. 14 to 21 are perspective views for explaining the operation (operation) of the in-vivo tissue closing device shown in FIG. 1, and FIGS. 15 to 21 (a) show the hand side. (B) shows the tip side.

  1 and 15 to 21, the upper cover of the casing is not shown, and the inner side of one rail (arrow F side) is shown.

  Moreover, in FIG. 1, the inside of the cover tube of the part enclosed with a broken line and the inside of a fixed tube are expanded and shown.

  Moreover, in FIG. 13, a cover tube and a fixed tube are each shown with a broken line, and in FIG. 14, a fixed tube is shown with a broken line.

  Further, in FIGS. 15 to 21, the illustration of the yarn is omitted except for a part in order to prevent the drawings from becoming complicated.

  For convenience of explanation, in FIGS. 1, 2, 10 to 13, and 15 to 21, the direction of arrow A in the drawing is “tip”, and the direction of arrow B (hand side) is “base end”. , The direction of arrow C is “up”, the direction of arrow D is “down”, and in FIGS. 3 to 8 and FIG. 14, the upper side in the figure is “base end” and the lower side is “tip”.

  The in-vivo tissue closing device 1 shown in these drawings is formed in an in-vivo tissue membrane such as a living body lumen such as a blood vessel, a living body internal organ, or a living body internal tissue, and has an undesired hole (a living body) penetrated percutaneously. It is a device that closes (closes) a wound hole penetrating through the body tissue membrane.

  As shown in FIGS. 1, 2, and 3, the in-vivo tissue closing device 1 is capable of penetrating a wound having a distal end penetrating the in-vivo tissue membrane, and has a proximal portion 9 on the proximal end side. And an in-vivo tissue closure device (closing device) that is detachably held (connected) at the distal end portion of the arrangement device 3 and closes a wound that penetrates the in-vivo tissue membrane. A clip 4 is provided.

  The clip 4 has a clip main body (closure main body) 40 and a thread (first thread-like body) 46 that is a holding means (fixing portion). The clip main body 40 has a seal portion 41 and a deformable deformation. It comprises a portion 42, and a connecting portion 44 that connects the seal portion 41 and the deformable portion 42 and inserts (penetrates) the wound. The thread 46 has a knot 461 and a ring 462. The clip 4 will be described in detail later.

  The placement device 3 is inserted into a sheath (elongate tube) 5 having a through-hole (lumen) 51 having a distal end penetrating a wound hole and penetrating in the axial direction at the center, that is, into the sheath 5. It is used by being detachably mounted (the sheath 5 is used by being detachably mounted on the placement device 3). The sheath 5 and the placement device 3 constitute a long main body 2. Further, at the time of hemostasis work (work for closing the wound), the sheath 5 and the distal end portion of the placement device 3 and the clip 4 respectively penetrate the wound. That is, it is inserted from a wound into a living body lumen (biological lumen) such as a blood vessel.

  The sheath 5 has a substantially cylindrical shape and has a hub (connector) 52 at the base end. Further, a hemostasis valve (valve element) in which a slit (not shown) is formed is provided on the inner peripheral side of the hub 52.

  A port portion (projection) 53 having a lumen (flow path) communicating with the through hole 51 is formed on the side portion of the hub 52.

  Further, a groove 54 is formed on the outer peripheral portion of the base end portion of the hub 52 over the entire circumference along the circumferential direction.

  As the sheath 5, for example, a sheath (introducer sheath) placed after treatment using a catheter (PCI) or diagnosis (CAG) may be used. It may be.

  In this embodiment, the sheath 5 is included in the components of the main body 2, but the sheath 5 may not be included in the components of the main body 2.

  The placement device 3 is detachably connected to the clip 4 (the thread 46 of the clip 4), the thread (second filament) 8 that holds the clip 4 (the thread 46 of the clip 4), and the tip portion is damaged. Cover tube (cover member) (cover means) 6 which is a long first tubular member (long portion) capable of penetrating the hole, and a long second shape whose tip portion can penetrate the wound hole. A fixed tube (locking member) (locking means) 7 which is a tubular member, and is positioned at the tip of the cover tube 6 in an initial state (a state immediately after assembly), and stores (holds) the clip 4. , A holding member (inserter) 18 that can move along the base end side (base end direction), and a proximal portion 9 provided on the base end side of the fixed tube 7 and the cover tube 6. When the holding member 18 moves to the proximal end side, the deformed portion 42 is pushed into an opening 61 described later of the cover tube 6 from the state where the clip 4 is held by the holding member 18, and the deformed portion 42 of the clip 4 covers the cover 4. The holding member 18 is a member having a function of being held in the opening 61 (tip portion) of the tube 6 and will be described in detail later.

  The clip 4 (the thread 46 of the clip 4) is detachably held by the thread 8 at the distal end portion of the arrangement device 3, and further, from this initial state until the holding member 18 is moved to the proximal end side. Is housed and held in the holding member 18. Note that the thread 8 has a portion of the clip 4 on the side opposite to the seal portion 41 (tip side) of the deformed portion 42 relative to the portion of the deformed portion 42 on the seal portion 41 side (base portion side) (base end side). The clip 4 is held so that it can be moved (displaced) automatically.

  The fixed tube 7 is concentrically installed (inserted) in the lumen (inside) of the cover tube 6, and the cover tube 6 moves (slids) in the longitudinal direction with respect to the fixed tube 7. Can be moved). The cover tube 6 and the fixed tube 7 are inserted into the through hole 51 of the sheath 5 when the sheath 5 is attached. Further, the hand portion 9 is provided on the base end side of the fixed tube 7 and the cover tube 6.

  The fixed tube 7 is formed of a relatively hard constituent material. The shape of the fixed tube 7 in the cross section is substantially elliptical (a shape obtained by smashing a circle) at the distal end portion 71, and is substantially circular at the base end side portion.

  In addition, a deformed portion 42 of the clip 4 is inserted at the distal end portion of the cover tube 6, and an opening 61 that can hold (mount) the deformable portion 42 in a detachable manner is formed. The opening 61 is located closer to the distal end than the distal end of the fixed tube 7. Further, the shape of the cover tube 6 in the cross section is substantially oval (a shape in which a circle is crushed) at the distal end, that is, the opening 61, and the proximal end portion (fixed tube) in the immediate vicinity thereof. 7), the shape corresponding to the distal end portion 71 of the fixed tube 7 is deformed into a substantially oval shape, and the proximal end portion is substantially circular. Yes.

  The thread 8 is installed (inserted) in the lumen (inside) of the fixed tube 7 and can move in the longitudinal direction of the fixed tube 7 with respect to the fixed tube 7.

  Further, when the cover tube 6 and the fixed tube 7 of the placement device 3 are inserted into the through-hole 51 from the proximal end side of the sheath 5 and the sheath 5 is positioned closest to the proximal end side, the cover tube 6 starts from the distal end of the sheath 5. The opening 61 is exposed (the distal end of the sheath 5 is located proximal to the distal end of the cover tube 6), and the distal end of the sheath 5 is located proximal to the distal end of the fixed tube 7.

  The cover tube 6 covers the outer surface of the fixed tube 7, and the opening 61 covers at least a part of the deformed portion 42 of the clip 4.

  On the other hand, when the thread 46 of the clip 4 is pulled in the proximal direction by the thread 8, the fixed tube 7 has the knot 461 of the thread 46 of the clip 4 locked on the distal end portion 71 of the fixed tube 7. The deformable portion 42 is locked (indirectly locked) through the position 461, and thereby the knot 461 is relatively moved in the distal direction, whereby the thread 46 is tightened to deform the deformable portion 42. .

  As shown in FIG. 1 and FIG. 2, the hand portion 9 includes a casing (main body) 11, a cover tube support portion (cover member support portion) 14 that supports the cover tube 6, and a thread support portion that supports the yarn 8 ( Holding member support portion 15, a pin (connecting means) 170 that is rotatably attached to the yarn support portion 15 and detachably connects the yarn 8 to the yarn support portion 15, a first charge member 32, and a second charge member 32. A charge connecting member 33, a slide connecting member (connecting means) 34 that removably connects the yarn support portion 15 and the second charge member 33, a pair of coil springs (springs) 22 that are elastic members (actuating members), It has a pair of guide bars 37, a lever (knob) 28, a lock portion 29 joined to the lower side of the lever 28, and a stopper 35. The first charging member 32 and the second charging member 33 constitute a charging unit.

  The casing 11 has an upper cover 11a located above and a lower cover 11b located below and joined to the upper cover 11a. The casing 11 has a cylindrical shape (rectangular cylindrical shape) whose outer shape is a substantially rectangular parallelepiped shape, and its base end side is rounded.

  The sheath 5 is fixed to the casing 11 at a distal end portion of the casing 11 via a mechanism for attaching the sheath 5 to the hand portion 9 (casing 11), that is, a holding member 18 and a base portion 321 of a first charge member 32 described later. As a mechanism, a connector 31 to which the base 321 of the first charge member 32 is fixed is provided. The connector 31 includes an inner tube portion 311 into which the base portion 321 is inserted, and an outer tube portion 312 installed on the outer periphery of the inner tube portion 311 so as to be rotatable (rotatable) in the circumferential direction.

  A straight elongated hole 313 that opens to the tip is formed in the peripheral wall of the inner tube portion 311, and a spiral elongated hole 314 that opens to the tip is formed in the peripheral wall of the outer tube portion 312. Yes. The outer tube portion 312 rotates with respect to the inner tube portion 311 in a predetermined direction until the distal end portion of the elongated hole 314 of the outer tube portion 312 and the distal end portion of the elongated hole 313 of the inner tube portion 311 coincide with each other. The base end of the long hole 314 and the base end of the long hole 313 can be rotated in the reverse direction.

  In addition, a plurality of (four in the illustrated example) ribs (projections) 315 that act as finger-hanging portions during operation are formed on the outer peripheral surface of the outer tube portion 312 at equal intervals (equal angular intervals). Yes.

  Further, in the central portion of the casing 11 and inside the upper cover 11a and the inner side of the lower cover 11b, grooves into which base end portions 325 of corresponding rod-like bodies 322 of the first charge member 32 described later are inserted, respectively. 91 are formed along the longitudinal direction of the arrangement | positioning apparatus 3 (casing 11) so that it may mutually oppose.

  In addition, a rib (projection) 92 is formed along the longitudinal direction of the arrangement device 3 (casing 11) at the base end portion of the casing 11 and inside the lower cover 11 b. A stepped portion 921 is formed on the distal end side of the distal end portion.

  A pair of protrusions 93 are formed at the tip of the casing 11 and inside the lower cover 11b. The first charge member 32, which will be described later, is prevented from moving in the proximal direction from the protrusion 93 by the base end portion of the base portion 321 being in contact with the pair of protrusions 93.

  In addition, a guide bar support portion 38 is provided (fixed) at the central portion in the casing 11, and a guide bar support portion 39 is provided (fixed) at the base end portion.

  The pair of guide bars 37 is disposed between the guide bar support portion 38 and the guide bar support portion 39, respectively, and the distal end portion of each guide bar 37 is held (supported) by the guide bar support portion 38, respectively. The base end portions are respectively held (supported) by the guide bar support portions 39. Moreover, each guide bar 37 is arrange | positioned so that it may mutually become parallel along the longitudinal direction of the arrangement | positioning apparatus 3 (casing 11), respectively.

  In addition, although each guide bar 37 is comprised with the pipe (tube | pipe) in the example of illustration, respectively, it is not restricted to this, For example, a solid may be sufficient.

  In addition, a pair of rails 36 are provided (fixed) from the guide bar support portion 38 to the guide bar support portion 39 on the side portion in the casing 11. Each rail 36 is arrange | positioned so that it may mutually become parallel along the longitudinal direction of the arrangement | positioning apparatus 3 (casing 11).

  Each rail 36 is formed with a groove 361 extending along its longitudinal direction (axial direction). Each groove 361 is formed inside the rail 36 so as to face each other.

  Further, when a pair of coil springs 22 (described later) are activated (restored) on the bottom (side wall) of the groove 361 of each rail 36, a base end portion 347 of a corresponding rod-shaped body 342 of a slide connecting member 34 (described later). A hole 362 into which is inserted is formed. Each hole 362 is located near the center of the rail 36.

  Further, in the casing 11, the first charge member 32, the second charge member 33, the guide bar support portion 38, the slide connecting member 34, and the thread support portion 15 are respectively attached to the casing 11. The placement device 3 (casing 11) is installed to be movable in the longitudinal direction.

  In this case, the first charge member 32, the second charge member 33, the slide connecting member 34, and the thread support portion 15 are arranged in this order from the distal end side toward the proximal end side. And the 2nd charge member 33 is arrange | positioned so that the guide bar support part 38 may be located between the front-end | tip part and a base end part.

  Further, the cover tube support portion 14 is disposed so as to be positioned between the guide bar support portion 38 and the base end portion of the second charge member 33.

  Further, the base portion 321 of the first charge member 32 is located on the distal end side from the connector 31.

  The slide connecting member 34 includes a base portion 341 and a pair of rod-like bodies 342 that protrude from both side portions of the base portion 341 toward the base end direction.

  At the base end portion 347 of each rod-shaped body 342, claws 343 are provided so as to face each other and protrude inward.

The base 341 is formed with a pair of holes 344 through which the pair of guide bars 37 are inserted.
A hole 345 through which the thread 8 is inserted is formed at the center of the base 341.

  Further, the base portion 341 is formed with a protrusion 346 that protrudes upward and is engaged with the protruding portion 291 of the lock portion 29.

  As shown in FIGS. 1, 2, and 9, protrusions 155 that engage with the corresponding claws 343 of the slide connecting member 34 are formed on both side portions of the tip portion of the thread support portion 15.

  Further, a recessed portion 150 opened upward and at the proximal end is formed on the proximal end side from the distal end portion of the yarn support portion 15.

  A pair of holes 156 through which the yarn 8 is inserted are formed at the tip of the yarn support portion 15. Further, a hole 157 through which the thread 8 is inserted is formed between the pair of holes 156 at the tip of the thread support 15.

  In addition, a pair of hole portions 158 through which the pair of guide bars 37 are inserted are formed at the tip of the yarn support portion 15.

  The pin 170 is composed of a base 171 and a protrusion 172 erected at the center of the base 171.

  The pin 170 is rotatably installed at the base portion 171 with respect to the thread support portion 15. The pin 170 is in an upright state in which the protrusion 172 (pin 170) is erected, and the prone position in which the protrusion 172 (pin 170) is laid down. It can be used in the fall state. The pin 170 is held in an upright state by the lower surface (back surface) of the base portion 171 being in contact with the upper surface of the rib 92 of the casing 11. The pin 170 is disposed in the concave portion 150 of the yarn support portion 15.

  The stopper 35 includes a C-shaped stopper main body 351 having a gap formed at the front end side (the front end side is open), and a support portion 352 that supports the stopper main body 351. The support portion 352 includes: It is installed (fixed) on the guide bar support part 39. A protrusion 172 of the pin 170 is inserted into the stopper main body 351 of the stopper 35. Thereby, the thread support 15 is held (locked) by the stopper 35 via the pin 170, and the movement of the thread support 15 is prevented. That is, the stoppers 35 prevent the pins 170 and the thread support portions 15 from moving in the distal direction with respect to the casing 11.

  Further, at least the stopper main body 351 of the stoppers 35 has an appropriate hardness and is configured to be elastically deformable. Further, the length (gap distance) of the gap on the tip side of the stopper main body 351 is set to be smaller than the outer diameter (diameter) of the protrusion 172 of the pin 170.

  As a result, the force applied to the yarn support portion 15 (pin 170) via the yarn 8, that is, the force (pull force) that pulls the yarn support portion 15 toward the distal end via the yarn 8 is a predetermined threshold ( The movement of the thread support portion 15 is prevented until the predetermined value) is exceeded, but when the threshold value is exceeded, the protrusion 172 of the pin 170 comes out of the gap in the stopper body 351 and the thread support portion 15 However, it can move in the distal direction with respect to the casing 11. In this case, as will be described later, the thread support portion 15 (the thread support portion 15, the slide connecting member 34, and the second charge member 33) can move in the distal direction, so that the coil spring 22 is in a contracted state (deformed state). , The restriction held in the active state) can be released. In other words, the restriction for holding the coil spring 22 in the contracted state can be released on condition that the force applied to the yarn support 15 exceeds a predetermined threshold value.

  The threshold value is preferably about 150 to 1500 gf, and more preferably about 200 to 1000 gf.

  As a result, even if the clip 4 is caught somewhat in the blood vessel or the like before the seal portion 41 of the clip 4 reliably contacts the wound hole and the surrounding tissue, the pin 170 comes out of the stopper 35 (the lock is released). ) It can be expected that the clip 4 comes off before, the clip 4 is moved to the wound hole, and the seal portion 41 can be brought into contact with the wound hole and the surrounding tissue. In addition, the pin 170 can be expected to come out of the stopper 35 (the lock is released) before the wound hole and the surrounding tissue are excessively pulled in the proximal direction by the clip 4, so that the sealing can be performed safely and reliably. The portion 41 can be brought into contact with the wound and the surrounding tissue.

  The thread 8 is formed of a double thread (double thread-like body) formed by folding one thread (thread-like body) and having one end portion serving as a folded-back portion 81. Further, the yarn 8 is inserted into each hole 156 of the yarn support portion 15 in the state of one yarn and wound once around the tip portion of the yarn support portion 15, and then the both ends thereof are tied together. It is attached to the support part 15.

  The thread 8 is inserted through the hole 157 of the thread support section 15 in a state where the clip 4 (the loop 462 of the thread 46 of the clip 4) is inserted and folded at the tip of the placement device 3 to hold the clip 4. Further, the folded portion 81 is hooked on the protrusion 172 of the pin 170, and the folded portion 81 is detachably connected to the thread support portion 15 by the pin 170. As described above, the other end (the end opposite to the folded portion 81) is attached to the yarn support portion 15.

  The second charge member 33 has a generally quadrangular prism (cuboid) bowl shape (frame shape).

  A hole 331 through which the cover tube 6 is inserted is formed at the tip of the second charge member 33.

  In addition, a pair of hole portions 333 through which the pair of guide bars 37 are inserted is formed at the proximal end portion of the second charge member 33. Further, a hole 332 through which the fixing tube 7 is inserted is formed between the pair of holes 333 at the base end of the second charge member 33.

  In addition, a pair of projecting portions 334 projecting from the upper and lower portions of the second charge member 33 toward the base end direction is provided upright. At the base end portion of each projecting portion 334, a claw 335 is provided so as to face each other and project inward. The pair of claws 335 engage with the base portion 341 of the slide connecting member 34.

  A pair of recesses 336 is formed at the upper and lower portions of the tip of the second charge member 33.

  The first charge member 32 includes a base portion 321 and a pair of rod-like bodies 322 that protrude from the upper and lower portions of the base end portion of the base portion 321 toward the base end direction.

  On the base end portion 325 of each rod-shaped body 322, a convex portion 323 is provided so as to face each other and project inward. The pair of convex portions 323 engages with the pair of concave portions 336 at the distal end portion of the second charge member 33.

  Further, as shown in FIG. 10, a hole 324 into which the cover tube 6 is inserted and the holding member 18 is inserted is formed at the center of the base 321 of the first charge member 32. A pair of claws 326 are provided in the hole 324.

  In addition, a protrusion 327 that protrudes laterally is formed on the outer surface (outer peripheral surface) of the base portion 321. The protrusion 327 is disposed at a position corresponding to the long hole 313 of the inner tube portion 311. Here, the protrusion 327 of the base portion 321 is in a state where the position of the distal end portion of the elongated hole 313 of the inner tube portion 311 of the connector 31 coincides with the position of the distal end portion of the elongated hole 314 of the outer tube portion 312. The first charge member 32 is moved in the proximal direction so as to be positioned at the distal end portion of the elongated hole 313 of the inner tube portion 311 and the distal end portion of the elongated hole 314 of the outer tube portion 312, so that the base portion 321 is moved into the inner tube portion 311. When the outer tube portion 312 is rotated in a predetermined direction (counterclockwise as viewed from the distal end direction in the illustrated example), the protrusion 327 is formed at the base end by the edge facing the elongated hole 314 of the outer tube portion 312. The base portion 321 is fixed to the casing 11 by being pushed in the direction and gradually moving in the proximal direction along the elongated hole 313 of the inner tube portion 311.

  The cover tube support part 14 is formed with a pair of hole parts 143 through which the pair of guide bars 37 are inserted, and the base end part of the cover tube 6 is a pair of hole parts 143 of the cover tube support part 14. It is fixed (supported) between.

  Further, the base end portion of the fixed tube 7 inserted into the cover tube 6 is fitted (fixed) to the base portion 341 of the slide connecting member 34.

  The outer diameter (diameter) of the main body of the fixed tube 7 is set smaller than the inner diameter (diameter) of the hole portion 332 at the base end portion of the second charge member 33.

  A pair of holes 333 in the second charge member 33, a pair of holes 143 in the cover tube support 14, a pair of holes 344 in the slide connecting member 34, and a pair of holes 158 in the thread support 15. A pair of guide bars 37 is inserted through each. Further, both side portions of the cover tube support portion 14 and the pair of rod-like bodies 342 of the slide connecting member 34 are respectively inserted into the grooves 361 of the pair of rails 36.

  As a result, the second charge member 33 and the yarn support portion 15 are each guided by the guide bars 37 along the longitudinal direction (axial direction) of the guide bars 37.

  Further, the cover tube support portion 14 and the slide connecting member 34 are guided along the longitudinal direction (axial direction) of the guide bar 37 and the rail 36 by the guide bar 37 and the rail 36, respectively.

  Here, in the initial state shown in FIG. 1 (the state immediately after assembly), the pair of convex portions 323 of the first charge member 32 is engaged with the pair of concave portions 336 at the tip of the second charge member 33. ing. Thereby, the 1st charge member 32 and the 2nd charge member 33 move integrally.

  In the initial state, a pair of claws 343 of the slide connecting member 34 are engaged with the pair of protrusions 155 at the tip of the yarn support portion 15. Thereby, the slide connection member 34 and the thread | yarn support part 15 move integrally. Strictly speaking, however, the stopper 35 and the lock portion 29 prevent the slide connecting member 34 and the thread support portion 15 from moving.

  In the initial state, the second charge member 33 and the slide connecting member 34 are separated by a predetermined distance. Thereby, the 1st charge member 32 and the 2nd charge member 33, the slide connection member 34, and the thread | yarn support part 15 move separately.

  Then, as will be described later, in the charged state (the state in which each coil spring 22 is held in the contracted state, which is an active state) shown in FIGS. 15 and 16, a pair of claws of the second charge member 33 335 engages with the base portion 341 of the slide connecting member 34 and disengages the pair of concave portions 336 at the distal end portion of the second charge member 33 and the pair of convex portions 323 of the first charge member 32. . As a result, the second charge member 33, the slide connecting member 34, the yarn support portion 15, and the fixed tube 7 move integrally, and the yarn support portion 15 moves relative to the fixed tube 7 ( Movement in the proximal direction) is prevented.

  In addition, among members that connect the clip 4, the thread support portion 15, and the casing 11 along the longitudinal direction of the placement device 3, a member that extends in the longitudinal direction of the placement device 3 such as a spring is included. Therefore, in the charged state, the distance between the clip 4 and the casing 11 is kept substantially constant until the force applied to the yarn support portion 15 via the yarn 8 exceeds the predetermined threshold value. Yes.

  The pair of coil springs 22 is disposed on the outer periphery of the pair of guide bars 37, respectively. Each coil spring 22 is inserted through the hole 344 of the slide connecting member 34 and is located between the proximal end portion of the second charge member 33 and the distal end portion of the yarn support portion 15. The base end of the second charge member 33 is in contact with the base end of the second charge member 33, and the base end of the second charge member 33 is in contact with the front end of the yarn support 15. In the initial state, each coil spring 22 is in a natural state or a slightly contracted state.

  In an initial state, the lever 28 is in a state in which relative movement between the slide connecting member 34 and the thread support portion 15 and the casing 11 is prevented (locked state) and in a state in which these relative movements are possible ( In the charged state, the second charge member 33, the slide connecting member 34, the thread support portion 15, the fixed tube 7 and the pair of coil springs 22 and the relative movement of the casing 11 are switched. It is an operation part (operation member) for performing operation which switches the state (lock state) from which this was blocked | prevented and the state (lock release state) in which these relative movement is possible.

  The lever 28 is installed on the outer upper surface of the upper cover 11a of the casing 11 so as to be movable (slidable) in the directions of arrows a and b shown in FIGS.

  And the lock | rock part 29 is joined to the lower side of the lever 28, and the lever 28 and the lock | rock part 29 move integrally. The lock portion 29 is located inside the upper cover 11 a of the casing 11. The lock portion 29 is provided with a protruding portion 291 that protrudes downward.

  When the lever 28 is located at the lock position shown in FIGS. 1 and 2, the protrusion 291 of the lock portion 29 abuts on the distal end side of the protrusion 346 of the slide connecting member 34, and the protrusion 346 is the protrusion 291. This prevents the slide connecting member 34 from moving in the distal direction. That is, the slide connecting member 34 is locked by the lock portion 29, and in the initial state, the slide connecting member 34 and the thread support portion 15 are prevented from moving in the distal direction. In the charged state, the second charge member 33 is blocked. The movement of the slide coupling member 34, the thread support portion 15, the fixed tube 7 and the coil springs 22 in the distal direction is prevented, and the operation of activating the coil springs 22 is prohibited.

  Further, when the lever 28 is moved in the direction of the arrow b (positioned at the unlocked position), the protruding portion 291 of the lock portion 29 moves to the side (the position without the projection 346) from the projection 346 of the slide connecting member 34. (Retracted), and the locking of the protrusion 346 to the protrusion 291 is released. Accordingly, the slide connecting member 34 can move in the distal direction on condition that the movement preventing state of the yarn support portion 15 by the stopper 35 is released (lock release). That is, the lock of the slide connecting member 34 by the lock portion 29 is released, and in the charged state, the second charge member 33, the slide connecting member 34, the yarn are provided on condition that the movement preventing state of the yarn support portion 15 by the stopper 35 is released. The support portion 15, the fixed tube 7, and each coil spring 22 can move in the distal direction, thereby enabling an operation to activate each coil spring 22.

  The lever 28 and the lock portion 29 constitute switching means for switching between a locked state in which the trigger means prohibits the operation of activating the pair of coil springs (activation members) 22 and an unlocked state in which the operation can be performed. Is done.

Next, the clip 4 will be described.
As shown in FIG. 3, the clip (in-vivo tissue closure device) 4 includes a clip body (closure body) 40 and a thread (first filament) 46 that is a holding means.

  The clip main body 40 includes a seal portion 41, a deformable deformable portion 42, and a connection portion 44 that connects the seal portion 41 and the deformable portion 42 and inserts a wound hole. It is preferable that the seal portion 41, the deformable portion 42, and the connection portion 44, that is, the clip body 40 are integrally formed of the same material.

  The seal portion 41 is in contact with the peripheral portion of the wound (the portion including the wound of the biological tissue membrane) from one surface (inner surface) side of the biological tissue membrane and covers the wound and the peripheral portion of the wound. It is a member having a portion (plane) 412 and has a plate shape.

  A surface (upper surface in FIG. 3) to which a later-described deformation portion 42 of the seal portion 41 is connected is substantially flat. Further, the seal portion 41 can swing around the portion where the connection portion 44 is provided (the angle with respect to the deformation portion 42 can be changed).

  Further, the length of the seal portion 41 differs from the connection portion 44 between the right portion in FIG. 3 and the left portion in FIG. 3. In other words, the length of the left portion from the connecting portion 44 is longer than the length of the right portion. Thereby, when closing the wound formed in the blood vessel wall, when the clip 4 is placed at the target site with the wound closed by positioning the longer part of the seal portion 41 on the upstream side of the blood flow. 3 can prevent the seal portion 41 from being inclined with respect to the blood vessel wall and the left end of the seal portion 41 in FIG. 3 from being buried in the blood vessel wall (the seal portion 41 and the blood vessel wall are reliably substantially omitted). Can be parallel).

  The deforming portion 42 has a pantograph-like shape made of a substantially rhomboid frame, and is connected (connected) to the substantially center of the flat portion 412 of the seal portion 41 via the connecting portion 44.

  That is, the deforming portion 42 extends in a direction substantially perpendicular to the seal portion 41, and contracts in a direction substantially parallel to the seal portion 41. Thus, it has a frame shape that is deformable between a second shape (second form) that contracts in a substantially vertical direction and expands in a direction substantially parallel to the seal portion 41. Accordingly, the deformable portion 42 is sealed from the basic shape (basic form) (natural state) shown in FIG. 3 to the shape (form) that can pass through the wound or from the other surface (outer surface) side of the in vivo tissue membrane. Arbitrary shape (form) between the first shape and the second shape, such as a shape (form) capable of sandwiching an in vivo tissue membrane (wound hole) with the part 41 and closing the wound hole Can be transformed into

  When the in-vivo tissue membrane is a blood vessel wall (biological lumen wall), the one surface is a surface distal to the body surface of the blood vessel wall (biological lumen wall), that is, the inner surface, and the other surface This surface is a surface proximal to the body surface of the blood vessel wall (biological lumen wall), that is, the outer surface.

  Here, in the present embodiment, the deforming portion 42 has a quadrangular annular shape by bending the belt-like body four times (a polygonal annular shape by bending the belt-like body a plurality of times). That is, the deformable portion 42 is formed by integrally forming four links, and has a quadrangular shape (quadratic frame shape) having four corner portions that can be bent in a hinge shape. 3 out of the two corners 421 and 422 at the diagonal positions in the vertical direction in FIG. 3, the corner 422 on the lower side (sealing part 41 side) in FIG. The flat portion 412 is connected to the approximate center and is a non-movable portion that cannot move with respect to the upper end of the connecting portion 44 in FIG.

  Accordingly, the deformable portion 42 can be deformed so that the corner portion 421 and the corner portion 422 approach and separate from each other, that is, can expand and contract in two orthogonal directions, and swings relative to the seal portion 41. You can also

  In addition, the upper surface (surface opposite to the seal portion 41) 423 of the upper corner (the side opposite to the seal portion 41) 423 in FIG. 3 of the two corner portions 421 and 422 forms a curved convex surface. Two holes (through holes) 425 and 428 are formed in the vicinity of the corner portion 421 of the deformable portion 42 (the end portion on the opposite side of the seal portion 41 of the deformable portion 42), and in the vicinity of the corner portion 422, Two holes (through holes) 426 and 427 are formed.

  Further, the upper part of the deformed part 42 above the two corners at the diagonal positions in the left-right direction in FIG. 3 is cut out at both sides, so that four step parts 429 are formed. ing. When the deformable portion 42 is pushed into the opening 61 of the cover tube 6, the tip of the cover tube 6 comes into contact with each stepped portion 429. Thereby, the amount of insertion of the deformable portion 42 into the opening 61 of the cover tube 6 is restricted. As a result, when the clip 4 is folded, the seal portion 41 can be inclined more greatly (laid down), and the clip 4 can be made more compact.

  Further, the connecting portion 44 has a plate shape, and a hole (through hole) 441 is formed near the center thereof. With this connection portion 44, the seal portion 41 and the corner portion 422 of the deformation portion 42 can be separated by a predetermined distance.

  The thread 46 is hung on the end of the deformable portion 42 opposite to the seal portion 41 and the end of the deformable portion 42 on the seal portion 41 side, and is attached to the clip body 40. In the present embodiment, the thread 46 is in the vicinity of the corner portion 421 of the deformable portion 42 (the end portion on the opposite side of the seal portion 41 of the deformable portion 42) and through the connecting portion 44, and the corner portion 421 of the deformable portion 42. Or it is hung on the vicinity and the connection part 44. That is, the thread 46 is inserted (penetrated) through the hole 425 of the corner portion 421 of the deformable portion 42, inserted through the hole 426 of the corner portion 422, and inserted through the hole 441 of the connecting portion 44 from the upper side in FIG. Then, the hole 427 of the corner portion 422 is inserted, the hole 428 of the corner portion 421 is inserted, and a knot 461 having a shape as shown in FIG. 4 or 5 is formed on the corner portion 421 side (outside the deformed portion 42). Forming. Such a knot is called a clinch knot. Further, a ring 462 through which the thread 8 is inserted is formed on the upper side in FIG. 3 of the knot 461.

  The knot 461 has a knot that is movable in the tip direction, that is, in the lower direction in FIG. 3. The knot 461 is moved on the thread 46 in the tip direction to tighten the thread 46, so that the deforming portion 42 is It can be deformed into a predetermined shape between the first shape and the second shape, and the state can be maintained (fixed). When the thread 46 holds the deformed portion 42 in the predetermined shape, the knot 461 is located at the end of the deformable portion 42 opposite to the seal portion 41, that is, at the corner portion 421. . Since the knot 461 is strongly tightened on the thread 46, the knot 461 does not move naturally in the proximal direction unless a strong force is applied.

  The knot 461 is formed larger than the inner diameter of the fixed tube 7, and the ring 462 is formed smaller than the inner diameter of the fixed tube 7. Thereby, when the knot 461 of the thread 46 of the clip 4 is moved by the fixing tube 7 and the thread 46 is tightened to deform the deforming portion 42, the ring 462 can enter the lumen of the fixing tube 7, Further, the knot 461 can be prevented from entering the lumen of the fixed tube 7, and the knot 461 can be moved reliably. In this way, the thread 46 functions as a holding unit that holds the deformable portion 42 in a predetermined shape (a shape in which a wound hole is sandwiched between the seal portion 41 from the other surface side of the in vivo tissue membrane).

  As described above, the thread 8 is inserted through the lumen of the fixed tube 7 with the ring 462 of the thread 46 inserted.

  The yarn 46 may also be used as the yarn 8. In this case, after the deformable portion 42 is fixed with the thread 46, the thread 46 may be cut with scissors or the like on the proximal end side from the knot 461.

  Further, the thread 46 is formed of a double thread (double thread-like body) in which one thread (a thread-like body) is folded and one end portion is a folded-back portion, and the loop 462 is formed by the folded-back portion. It may be formed.

  At least a part of the clip body 40 of the clip 4 is preferably made of a bioabsorbable material, more preferably a main part of the clip body 40 is made of a bioabsorbable material. The whole, that is, the seal part 41, the deforming part 42, and the connection part 44 are preferably configured integrally with a bioabsorbable material. Thereby, since the clip main body 40 is absorbed by the living body after a predetermined period and does not finally remain in the living body, the influence on the human body can be eliminated. The thread 46 is also preferably made of a bioabsorbable material.

  Examples of the bioabsorbable material used include simple substances such as polylactic acid, polyglycolic acid, and polydioxanone, or composites thereof.

  In addition, as a constituent material of the clip main body 40 of the clip 4, not only a bioabsorbable material but biocompatible materials, such as various resin materials (polymer) and a metal material, can be used, for example. Further, the constituent material of the thread 46 is not limited to the bioabsorbable material.

Moreover, as the clip main body 40 of the clip 4, it is desirable that the material properties required for the deformation function of the deformation portion 42 are excellent in hinge characteristics. Specifically, the tensile strength is 250 to 500 (Kg / cm ² ), the elongation is 150 to 800%, the tensile elastic modulus is 8 to 20 (× 10 ³ Kg / cm ² ), and the bending strength is 300 to 700 (Kg / cm). ² ) is preferable. By satisfying these physical property values, the clip body 40 is excellent in hinge characteristics, and the deformable portion 42 can have a desired deformability.

  As shown in FIG. 14, the deformed portion 42 of the clip 4 is detached from the distal end portion of the cover tube 6, and the thread 46 of the clip 4 is pulled in the proximal direction by the thread 8 while the deformable portion 42 is deformable. Then, the knot 461 of the thread 46 of the clip 4 is locked to the tip 71 of the fixed tube 7, and the deformed portion 42 is locked (indirectly locked) via the knot 461. The knot 461 moves in the distal direction, the thread 46 is tightened, and the deforming portion 42 is deformed.

  In this case, when the clip 4 is held in the opening 61 of the cover tube 6, the deformed portion 42 of the clip 4 is in a direction substantially perpendicular to the seal portion 41 (see FIG. 14A). The cover tube 6 extends in the longitudinal direction (axial direction) and is reduced in a direction substantially parallel to the seal portion 41 (radial direction of the cover tube 6). Then, as the knot 461 moves in the distal direction and the thread 46 is tightened, the corner portion 421 of the deformable portion 42 moves downward in FIG. 14, and the deformable portion 42 is shown in FIG. From the shape, the shape shown in FIG. 14 (b) and the shape shown in FIGS. 14 (c) and 14 (d) can be used to sandwich the tissue membrane between the seal portion 41 and the deformable portion 42 and close the wound. Deforms continuously. That is, the deformable portion 42 contracts in a direction substantially perpendicular to the seal portion 41 (longitudinal direction of the cover tube 6) and expands in a direction substantially parallel to the seal portion 41 (radial direction of the cover tube 6). go.

  Further, as described above, the knot 461 is knotted so that it can be moved in the distal direction only when a strong force is applied, so that the thread 46 keeps the deformed portion 42 in a predetermined shape. Is done.

  As described above, according to the clip 4, the degree of deformation of the deformation portion 42 can be continuously restricted (adjusted) (the distance between the two corner portions 421 and 422 is continuously restricted (adjusted)). can do). That is, in a state where the deforming portion 42 has a desired shape, the state can be maintained. Thereby, for example, it is possible to cope with various cases such as a thick person, a thin person, a hard person, a soft person, etc. (such as various vascular membrane states (situations)). Can respond.

  In the present invention, it goes without saying that the configuration of the clip (in vivo tissue closure device) is not limited to the above as long as it has a seal portion, a deformation portion, and a holding means.

  For example, in the present invention, the shape of the deformed portion of the clip is not limited to a quadrangle, but may be another polygonal shape, or may be a frame shape having no corners such as an annular shape or an elliptical shape.

  Further, the deformed portion of the clip may be composed of, for example, a sponge-like porous body (porous material) or a fiber aggregate mainly made of biodegradable resin material (synthetic resin material) such as collagen. it can.

  Further, the clip holding means is not limited to a thread-like body, and for example, a clip body (a closure body) provided (integrally formed), for example, a plate-like body or a rod-like body Good.

  The clip 4 has a swelling portion (swelling layer) 47 on at least a part of its outer surface (surface). In this embodiment, as shown in FIGS. 3 and 6 to 8, the swelling portion 47 has a surface on the deformed portion 42 side of the seal portion 41 (an upper surface in FIGS. 6 and 7) and a side surface (in FIG. 7). Left side surface and right side surface), and opposed surfaces of the deformed portion 42 to the seal portion 41 when the deformed portion 42 has the second shape (the lower left surface and the lower right surface in FIG. 6), The outer surfaces of the side surfaces (left and right surfaces in FIG. 8) corresponding to the facing surface and the inclined surface 424 between the facing surface and the side surface of the portion corresponding to the facing surface are respectively It is provided to cover.

  Each swelling portion 47 is made of a swellable material (material) that comes into contact with a liquid and absorbs the liquid to swell (expand) (increase in volume).

  By providing the swelling portion 47 on the surface of the seal portion 41 on the deformation portion 42 side, when the swelling portion 47 swells, the seal when the seal portion 41 and the deformation portion 42 sandwich the wound hole and the peripheral portion of the wound hole. The distance between the portion 41 (planar portion 412) and the deformed portion 42 is reduced, whereby the seal portion 41 and the deformed portion 42 can tighten (pinch) the wound hole and the peripheral portion of the wound hole more strongly. And the wound can be closed more reliably.

  Further, by providing the swelling portion 47 on the side surface of the seal portion 41, when the swelling portion 47 swells, the area (width W1 shown in FIG. 3) of the surface of the seal portion 41 (plane portion 412) on the deformed portion 42 side is increased. This increases the area of the seal portion 41 that covers the wound hole and the peripheral portion of the wound hole, and more reliably covers the wound hole and the peripheral portion of the wound hole from the inner surface side of the in vivo tissue membrane. The wound can be closed more reliably. Moreover, it can prevent that the seal | sticker part 41 falls outside from a wound hole.

  Moreover, when the swelling part 47 swells by providing the swelling part 47 on the surface facing the seal part 41 of the deformation part 42 when the deformation part 42 has the second shape, the seal part 41 and the deformation part 42 The distance between the seal portion 41 (planar portion 412) and the deformed portion 42 when the wound hole and the peripheral portion of the wound hole are sandwiched between the seal portion 41 and the deformable portion 42 is reduced. The periphery of the wound can be tightened (pinched) more strongly, and the wound can be closed more reliably.

  Moreover, when the swelling part 47 is swelled by providing the swelling part 47 on the side surface of the part corresponding to the surface facing the seal part 41 of the deformation part 42 when the deformation part 42 has the second shape, the deformation part 42 The area of the facing surface of the seal portion 41 with respect to the seal portion 41 (width W2 shown in FIG. 3) increases, thereby increasing the area of the deformed portion 42 that covers the wound hole and the periphery of the wound hole, and more reliably in vivo. The wound hole and the periphery of the wound hole can be covered from the outer surface side of the tissue membrane, and the wound hole can be closed more reliably. Moreover, it can prevent that the deformation | transformation part 42 slips out from a wound hole inside.

  Further, by providing the swelling portion 47 on the inclined surface 424 between the facing surface of the deforming portion 42 when the deforming portion 42 has the second shape and the side surface of the portion corresponding to the facing surface. The effect obtained when the swelling portion 47 is provided on the facing surface and the effect obtained when the swelling portion 47 is provided on the side surface of the portion corresponding to the facing surface are obtained.

  Further, it is preferable that the swelling portion 47 is not provided on the outer surface of the connection portion 44. In the present embodiment, the swelling portion 47 includes a surface and a side surface on the deformation portion 42 side of the seal portion 41, a surface facing the seal portion 41 of the deformation portion 42 when the deformation portion 42 has the second shape, and a surface facing the surface. Are not provided on the outer surface of the portion other than the side surface and the inclined surface 424.

  Since the connection part 44 is inserted through the wound hole, by not providing the swelling part 47 on the outer surface of the connection part 44, it is possible to prevent the wound hole from expanding due to swelling of the swelling part 47, and more. The wound can be reliably closed.

  In addition, since the structure of each swelling part 47 is the same, below, the predetermined one swelling part 47 is typically demonstrated below.

  The swelling material constituting the swelling part 47 is not particularly limited as long as it swells in contact with a liquid, but a gel polymer is preferable. In the present embodiment, a case where a gel polymer is used as the swellable material will be described.

  The gel polymer that constitutes the swelling portion 47 has a property that its volume changes upon contact with a liquid.

  That is, the gel polymer does not form a gel state in a dry state (shrinked state) before gelation, but swells (swells) and takes a gel state (becomes jelly-like) by taking a liquid into the inside. It is what has. In addition, the gel polymer swollen in this manner has a property of releasing the taken-in liquid and contracting when it comes into contact with a liquid having a predetermined property.

  That is, this gel polymer can select swelling (expansion) and shrinkage depending on the property of the liquid in contact. Such gel polymers are commonly referred to as “environmentally sensitive gel polymers”.

  The environment-sensitive gel polymer is a crosslinked product obtained by polymerizing and crosslinking an environment-sensitive monomer component or prepolymer component, and is composed of a polymer having a three-dimensional network structure.

  Such an environmentally sensitive gel polymer has pores in the gaps between the molecular chains. The pores expand and contract according to the bonding force between the molecular chains, but the bonding force between the molecular chains varies depending on the environment in which the gel polymer exists. Due to such properties, the environment-sensitive gel polymer can take in the liquid into the pores and discharge the taken-in liquid in accordance with the change in the environment.

  Examples of the monomer component or prepolymer component of the environmentally sensitive gel polymer include acrylic acid, methacrylic acid, or derivatives thereof, styrene sulfonic acid, vinyl sulfonic acid, vinyl phosphoric acid, vinyl pyridine, trimethyl vinyl pyridinium hydrochloride, and acryloylamino. Examples thereof include propyltrimethylammonium hydrochloride, dimethylmethacryloyloxyethylammonium propane sulfonic acid, and the like, and one or a mixture of two or more of these can be used.

  Among these, acrylic acid, methacrylic acid, or derivatives thereof are particularly preferably used. Acrylic acid, methacrylic acid, or derivatives thereof are environmentally sensitive monomer components (prepolymer components), and the gel polymer containing them has an ionic functional group, which will be described later. It will be a thing.

  In addition to the above, the monomer component or prepolymer component of the environmentally sensitive gel polymer may be ethylenically unsaturated such as 2-hydroxyethyl acrylate, 2-hydroxyethyl methacrylate, acrylamide or methacrylamide, or derivatives thereof. Preferably it contains monomers.

  Of these, acrylamide is particularly preferably used. By including acrylamide, the mechanical properties of the gel polymer can be enhanced.

  The monomer component or prepolymer component preferably has an ionic functional group in part of its molecular structure. As a result, the environment-sensitive gel polymer selectively increases in swelling rate (expansion rate) and shrinkage rate depending on the composition of the liquid in contact with the concentration of ions contained, and the like. In addition, since the hydrophilicity of the environment-sensitive gel polymer is increased, more liquid can be actively absorbed and swollen.

  Here, when the ionic functional group is an anionic group, that is, when the environmentally sensitive gel polymer has an anionic group as part of its molecular structure, the environmentally sensitive gel polymer swells by deprotonation. To do. In addition, the swollen environment-sensitive gel polymer contracts when protonated. Accordingly, the environmentally sensitive gel polymer swells by contact with a liquid having a deprotonation effect, and then contracts by contact with a liquid having a protonation effect.

  Examples of the anionic group include a carboxylic acid group, a mercapto group, a phosphoric acid group, and a sulfonic acid group.

  On the other hand, when the ionic functional group is a cationic group, that is, when the environmentally sensitive gel polymer has a cationic group as part of its molecular structure, the environmentally sensitive gel polymer swells by being protonated. In addition, the swollen environment-sensitive gel polymer contracts by deprotonation. Accordingly, the environmentally sensitive gel polymer swells by contact with a liquid having a protonation effect and then contracts by contact with a liquid having a deprotonation effect.

Examples of the cationic group include an amino group and an ammonium base.
Moreover, as an environment sensitive gel polymer, what has pH responsiveness is preferable, and what specifically swells by contact with the body fluid (tissue fluid) around a blood and a wound is preferable, respectively. That is, it swells by contact with a liquid having a pH of about 7.1 to 7.8, and preferably does not swell by contact with a liquid having a pH of less than 7.1 and a liquid having a pH of more than 7.8, More preferably, the liquid swells by contact with a liquid having a pH of about 7.2 to 7.6, and does not swell by contact with a liquid having a pH of less than 7.2 and a liquid having a pH of more than 7.6. More preferably, the liquid swells by contact with a liquid having a pH of 7.4, and does not swell by contact with a liquid having a pH of less than 7.4 and a liquid having a pH of more than 7.4.

  Thereby, the swelling part 47 does not swell in contact with, for example, physiological saline (the physiological saline has a pH of 7) or the like, but from when it comes into contact with blood or body fluid around the wound, that is, the clip Swelling begins when 4 closes the wound and is placed at the target site. As a result, the clip 4 can be placed in the target site smoothly and reliably.

  Moreover, as an environment sensitive gel polymer, what swells so that the volume may become about 3-5 times is preferable, and what swells so that it may become about 3.5-4 times is more preferable.

  Moreover, the thickness of the swelling part 47 is not specifically limited, Although it determines suitably according to various conditions etc., the thickness before swelling (at the time of non-swelling) (dry state) is 0.025-0.375 mm. Is preferably about 0.0375 to 0.25 mm.

  If the thickness of the swelling part 47 before swelling is smaller than the lower limit, the thickness of the swelling part 47 after swelling becomes small, and depending on other conditions, a sufficient effect may not be obtained. If it is larger than the upper limit, depending on other conditions, the body 2 (for example, the placement device 3 or the sheath 5) of the in-vivo tissue closing device 1 may not be entered.

  Moreover, it is preferable that the thickness after the swelling of the swelling part 47 is about 0.1-1.5 mm, and it is more preferable that it is about 0.15-1.0 mm.

  If the thickness after swelling of the swollen portion 47 is smaller than the lower limit value, a sufficient effect may not be obtained depending on other conditions. If the thickness is larger than the upper limit value, scratches may be generated depending on other conditions. In some cases, a tissue membrane (for example, a blood vessel) in which a hole is formed is deformed.

  Further, the surface of the portion of the clip body 40 where the swelling portion 47 is formed preferably has higher hydrophilicity than the surface of the portion where the swelling portion 47 is not formed.

  Thereby, the adhesiveness of the clip main body 40 and the swelling part 47 improves, and it can prevent that the swelling part 47 peels from the clip main body 40. FIG. In addition, the swollen portion 47 can be more reliably formed only on the surface of the portion of the clip body 40 where the swollen portion 47 is formed.

  In order to increase the hydrophilicity of the surface of the portion where the swelling portion 47 of the clip body 40 is formed, for example, the surface is subjected to a hydrophilic treatment. Thereby, the hydrophilicity of the surface of the site | part which forms the swelling part 47 of the clip main body 40 becomes higher than before a hydrophilization process, and, thereby, becomes higher than another site | part.

  Examples of the hydrophilic treatment include plasma treatment, ozone oxidation treatment, and surface roughening treatment (rough surface processing) such as sand blasting and shot blasting, and one or more of these are used in combination. be able to.

  Note that the entire outer surface of the clip body 40 may be subjected to a hydrophilic treatment, but it is preferable not to perform the hydrophilic treatment on the outer surface of the connection portion 44. By not performing the hydrophilic treatment on the outer surface of the connection portion 44, it becomes difficult to form the swelling portion 47 on the outer surface of the connection portion 44.

  Here, when the solution containing the material constituting the swelling part 47 is applied to the clip body 40 by using, for example, a dipping method, and the swelling part 47 is formed, the part where the swelling part 47 of the clip body 40 is formed So that the solution adheres to (applies to) the clip body 40 between the hydrophilic size (height) of the surface of the surface and the hydrophilic size of the surface of the portion where the swelling portion 47 is not formed. It is preferable to adjust the hydrophilicity of the surface of each part of the solution or clip body 40.

  Thereby, the solution can be applied to only the surface of the portion of the clip body 40 where the swelling portion 47 is formed, and the swelling portion 47 can be formed easily and reliably.

  Next, a method for forming the swelling portion 47 of the clip 4 on the clip body 40 (a method for producing the clip body 40) will be described.

  [1] First, a raw material for forming the swelling portion 47, that is, a solution containing a material constituting the swelling portion 47 is prepared.

  That is, first, a monomer component (prepolymer component), a crosslinking agent, a polymerization initiator, and a solvent that are raw materials for the gel polymer are prepared. And these are mixed and a solution is prepared. As a result, a gel polymer is obtained in which the monomer component is polymerized and is three-dimensionally crosslinked to form a three-dimensional network structure.

  In addition, it is preferable that the content rate of the environment sensitive monomer component in all the monomer components is about 10-50 mass%, and it is more preferable that it is about 10-30 mass%.

  Moreover, the content rate of the monomer component in a solution is although it does not specifically limit, Preferably it is about 20-30 mass%.

  Examples of the crosslinking agent include N, N′-methylenebisacrylamide, ethylene glycol di (meth) acrylate, diethylene glycol di (meth) acrylate, triethylene glycol di (meth) acrylate, polyethylene glycol di (meth) acrylate, and trimethylol. Examples thereof include ethylenically unsaturated compounds such as propane tri (meth) acrylate, pentaerythritol tri (meth) acrylate, divinylbenzene, and divinyl ether. Since the ethylenically unsaturated compound functions as a crosslinking agent that can reliably form a three-dimensional network structure with the monomer component, it is particularly suitable as a crosslinking agent for forming the swelling portion 47.

Of these, N, N′-methylenebisacrylamide is more preferably used.
Although the content rate of the crosslinking agent in a solution is not specifically limited, Preferably it is less than 1 mass%, More preferably, you may be less than 0.1 mass%.

Examples of the polymerization initiator include ammonium persulfate, N, N, N ′, N′-tetramethylethylenediamine, and the like.
Moreover, water, ethanol, etc. can be used for a solvent, for example.

  Furthermore, a pore-forming agent may be included in the solution as necessary. Thereby, a porous thing is obtained as swelling part 47. FIG. Since the porous swelling portion 47 has a large surface area, the liquid absorption rate is high, and the swelling rate (expansion rate) is high.

  Examples of the pore-forming agent include sodium chloride, potassium chloride, ice, sucrose, sodium bicarbonate and the like.

  The average particle diameter of the pore former is preferably about 1 to 25 μm, more preferably about 3 to 10 μm.

  Furthermore, it is preferable that the content rate of the pore making material in a solution is about 5-50 mass%, and it is more preferable that it is about 10-20 mass%.

  Moreover, the particle | grains comprised with the radiopaque material may be included in the solution as needed. Thereby, X-ray contrast property is acquired in the swelling part 47, and the position of the clip 4 (swelling part 47) can be easily confirmed under X-ray fluoroscopy.

  [2] Next, the surface of the portion of the clip body 40 where the swelling portion 47 is formed, that is, in this embodiment, the surface and the side surface of the seal portion 41 on the deformation portion 42 side, and the deformation portion 42 have the second shape. The surface of the deformable portion 42 facing the seal portion 41, the side surface of the portion corresponding to the facing surface, and the inclined surface 424 are each subjected to a hydrophilic treatment.

  [3] Next, the surface and the side surface of the seal portion 41 on the deformed portion 42 side, the facing surface of the deformable portion 42 when the deformed portion 42 has the second shape, and the portion corresponding to the facing surface. The obtained solution is applied to each of the side surface and the inclined surface 424 to form a gel polymer layer, that is, a swollen portion 47 (swelled portion 47 in a swollen state).

  Examples of the solution application method include a dipping method, a brush coating method, a dispenser method, and the like. In this case, as described above, by using the dipping method, the solution can be easily and surely applied only to the surface of the portion of the clip body 40 where the swelling portion 47 is formed.

  [4] Next, the swelling part 47 is washed with a washing liquid. Thereby, unreacted residual monomer components, pore formers, and the like are removed.

  [5] Next, a pretreatment for controlling the swelling speed (expansion speed) of the swollen portion 47 after washing is performed.

  Since this pretreatment differs depending on the characteristics of the ionic functional group in the gel polymer, each will be described.

  [5-a] When the gel polymer has an anionic group, this pretreatment is performed by bringing a liquid (treatment liquid) that protonates the anionic group into contact with the gel polymer after washing. . By contact with the treatment liquid, the anionic group is protonated and a cohesive force based on hydrogen bonds is generated between the molecular chains. For this reason, the space between the molecular chains becomes narrow, and the gel polymer contracts.

  At this time, the time for immersing the gel polymer in the treatment liquid and the temperature of the treatment liquid are directly proportional to the swelling rate of the gel polymer. On the other hand, the pH of the treatment liquid is inversely proportional to the swelling rate of the gel polymer.

  The gel polymer subjected to such pretreatment can be swollen more quickly when it is swollen by appropriately setting the conditions of the treatment liquid.

  [5-b] When the gel polymer has a cationic group, this pretreatment is performed by bringing the gel polymer after washing into contact with a liquid (treatment liquid) that deprotonates the cationic group. Is called. By contact with the treatment liquid, the cationic group is deprotonated and a cohesive force is generated between the molecular chains. For this reason, the space between the molecular chains becomes narrow, and the gel polymer contracts.

  At this time, the time for immersing the gel polymer in the treatment liquid, the temperature of the treatment liquid, and the pH of the treatment liquid are each directly proportional to the swelling rate of the gel polymer.

  The gel polymer subjected to such pretreatment can be swollen more quickly when it is swollen by appropriately setting the conditions of the treatment liquid.

  [6] Next, the swollen swelling portion 47 is dried. Thereby, the swelling part 47 of a dry state (shrinking state) is formed, and the clip main body 40 is obtained.

  Here, in the present invention, the swollen portion 47 is formed on the inner surfaces (surfaces) of the holes 426 and 427 formed on the surface of the deformable portion 42 facing the seal portion 41 when the deformable portion 42 has the second shape. Preferably it is provided. Accordingly, when the swelling portion 47 swells, the holes 426 and 427 are reduced or closed, and the area of the surface of the deformable portion 42 facing the seal portion 41 is increased. The site | part which covers the peripheral part of a wound hole becomes large, can cover a wound hole and the peripheral part of a wound hole from the outer surface side of a biological tissue membrane more reliably, and can close a wound hole more reliably.

  In the present invention, it is preferable that the swelling portion 47 is provided on the upper surface of the deformable portion 42 in FIG. 3 (particularly, the upper surface 423 of the corner portion 421). Thereby, if the swelling part 47 swells, the fastening force of the thread | yarn 46 will increase and it can close a wound hole more reliably.

  In this embodiment, the swelling portion 47 is provided in each of the seal portion 41 and the deformation portion 42. However, in the present invention, the swelling portion 47 is not limited to this, and the swelling portion 47 includes the seal portion 41 and the deformation portion 42. It may be provided in any one of these.

  Moreover, as a constituent material of the swelling part 47, if it is a swelling material which swells in contact with a liquid, it will not be limited to the material mentioned above, For example, polyvinyl alcohol etc. are mentioned.

Next, the holding member 18 will be described.
As shown in FIGS. 11 to 13, the holding member 18 has a substantially cylindrical shape as a whole, and includes a proximal end member 18 a disposed on the proximal end side and a distal end side member 18 b disposed on the distal end side. Has been.

  The proximal end side member 18a and the distal end side member 18b are integrated by fitting the distal end side member 18b on the inner side (inner peripheral side) of the proximal end side member 18a. In addition, a pair of convex portions 181 are formed on the outer peripheral portion of the distal end side member 18b, and side holes 182 are formed in portions corresponding to the respective convex portions 181 of the proximal end side member 18a. Thereby, when the proximal end member 18a and the distal end side member 18b are fitted, each convex portion 181 of the distal end side member 18b is engaged with an edge facing the corresponding side hole 182 of the proximal end side member 18a. The proximal end member 18a and the distal end side member 18b are fixed to each other. In FIGS. 11 and 13, only one of the convex portions 181 and the side holes 182 is visible. Hereinafter, the holding member 18 in a state in which the proximal end member 18a and the distal end side member 18b are integrated, not individually will be described.

  A pair of ribs (protrusions) 183 that can be inserted into the groove 54 of the hub (connector) 52 of the sheath 5 and engage with the surface in the groove 54 is formed on the inner peripheral portion on the distal end side of the holding member 18. Has been. Each rib 183 is formed along the circumferential direction. By the ribs 183 and the grooves 54, the holding member 18 and the hub 52 of the sheath 5 are connected, and the state is held. Therefore, each rib 183 and the groove 54 constitute a first connection portion that connects the holding member 18 and the hub 52 of the sheath 5.

  Further, a groove 184 into which a pair of claws 326 of the base portion 321 of the first charge member 32 is inserted is formed on the outer peripheral portion on the proximal end side of the holding member 18, and each claw is formed on the surface in the groove 184. 326 can be engaged. The groove 184 is formed over one circumference along the circumferential direction. By the grooves 184 and the claws 326, the holding member 18 and the hand portion 9 are connected and the state is held. Therefore, the groove 184 and each claw 326 constitute a second connection portion that connects the holding member 18 and the hand portion 9.

  The holding member 18 is provided with a wide space portion 191 in which a relatively wide space (lumen) (wide space) is formed, and a space (narrower than the wide space portion 191) provided at the tip side of the wide space portion 191. A narrow space portion 192 in which a narrow space is formed, and a transition portion 193 provided between the wide space portion 191 and the narrow space portion 192 and in which a space communicating with the wide space and the narrow space is formed. And a storage unit 190 having In addition, the size of the area in the cross section (cross section perpendicular to the axis) of the space is defined as the width (large or small) of the space.

  The wide space portion 191 has the widest space, and is composed of a widest space portion 1911 provided on the distal end side and a proximal end side space portion 1912 provided on the proximal end side.

  In an initial state (a state immediately after assembly), the clip 4 is stored (held) in the storage portion 190 (in this embodiment, the wide space portion 191 and the transition portion 193). In this case, most of the deformed portion 42 of the clip 4 is accommodated in the proximal end side space portion 1912 of the wide space portion 191, and the remaining portion is accommodated in the widest space portion 1911. The seal portion 41 is housed in the transition space 193 and the widest space portion 1911 of the wide space portion 191.

  The inner shape (the shape of the space) in the cross section of the proximal end side space portion 1912 has a substantially quadrangular shape, and each vertex thereof is rounded. Further, the predetermined pair of sides of the quadrangle is directed in a direction perpendicular to the paper surface of FIG. 13, and the other pair of sides is directed in the vertical direction in FIG. Thereby, the clip 4 is accommodated in such a posture that the direction of the width W1 shown in FIG. 3 of the seal portion 41 is perpendicular to the paper surface of FIG.

  In the initial state, in the illustrated configuration, the clip 4 may have a slight load applied to the deformed portion 42 from the proximal end side space portion 1912 to such an extent that there is no problem. The cover tube 6 is housed in a state in which a load to be crushed in the radial direction of the cover tube 6 is slightly applied (a state in which the cover tube 6 is slightly folded so as to extend in the longitudinal direction).

  When assembling the in-vivo tissue closing device 1, the base end side member 18a and the front end side member 18b are fitted and integrated after the clip 4 is stored in a predetermined position of the storage portion 190. As a result, the clip 4 can be stored in the storage unit 190 without applying a load that causes a problem to the deformed portion 42 of the clip 4.

  Note that the clip 4 may be accommodated such that the deformation portion 42 is not loaded at all and the deformation portion 42 is not deformed at all. Further, the clip 4 may be stored only in the wide space 191.

  In the initial state, the cover tube 6 and the fixed tube 7 are inserted into the lumen of the holding member 18 from the proximal end of the holding member 18. In this case, the opening 61 of the cover tube 6 is located in the wide space portion 191, and the distal end portion 71 of the fixed tube 7 is located at a position closer to the proximal end than the wide space portion 191 of the holding member 18. Since the relatively hard fixing tube 7 is located in the inner cavity of the holding member 18, it is possible to prevent the cover tube 6 from being bent (kinked).

  Further, the inner shape (the shape of the lumen) in the cross section of the portion (base end portion 186) closer to the base end side than the wide space portion 191 of the holding member 18 is substantially elliptical. On the other hand, as described above, the shape of the distal end portion 71 of the fixed tube 7 in the cross section and the shape of the cover tube 6 corresponding to the distal end portion 71 of the fixed tube 7 are substantially elliptical. Therefore, the rotation of the cover tube 6 and the fixed tube 7 with respect to the holding member 18 can be prevented. The direction of the ellipse is set so that the deformed portion 42 of the clip 4 is inserted into the opening 61 of the cover tube 6 when the holding member 18 moves to the proximal end side.

  The dimension in the cross section is set to be larger in the opening 61 of the cover tube 6 than in the lumen of the proximal end 186 of the holding member 18. Thereby, it is possible to prevent the holding member 18 from being detached from the distal end portion of the cover tube 6.

  Further, the inner diameter of the most proximal end portion 187 of the holding member 18 gradually increases from the distal end side toward the proximal end side. In addition, the surface of the part is rounded. Thereby, when the holding member 18 is moved to the proximal end side, it is possible to prevent the cover tube 6 from buckling.

  Further, the inner diameter of the boundary portion between the proximal end portion 186 and the most proximal end portion 187 of the holding member 18 is such that blood does not leak from the gap between the holding member 18 and the cover tube 6 or the leakage amount is It is preferable to set so as to be very small. That is, the inner diameter of the boundary portion between the base end portion 186 and the most base end portion 187 of the holding member 18 is preferably set slightly smaller than the outer diameter of the cover tube 6.

  Further, the holding member 18 is configured so that the clip 4 is inserted into the narrow space portion 192 through the transition portion 193 when the holding member 18 moves to the proximal end side.

  The transition part 193 has an inclined surface 194 on the lower side in FIG. The inclined surface 194 is inclined so that the proximal end side is positioned below the distal end side in FIG. 13 (inclined from the distal end side toward the proximal end side).

  When the holding member 18 moves to the proximal end side, the clip 4 is gradually folded along the inclined surface 194. That is, the seal portion 41 of the clip 4 is gradually inclined along the inclined surface 194.

  On the other hand, the upper surface in FIG. 13 of the transition portion 193 is not inclined. Thereby, the clip 4 can be folded smoothly.

  Further, when the clip 4 is inserted into the narrow space portion 192, the load applied to the deformed portion 42 increases, and the deformed portion 42 is compressed more than in the initial state, and the clip in the basic shape shown in FIG. 4 extends in a direction substantially perpendicular to the seal part 41 (longitudinal direction of the cover tube 6) and contracts in a direction substantially parallel to the seal part 41 (radial direction of the cover tube 6) (FIG. a)). As a result, the clip 4 is completely folded, and in the folded state (the deformed portion 42 is compressed), the deformed portion 42 is pushed into the opening 61 of the cover tube 6 and held (opened). (Refer FIG.16 (b) about the part 61 and the deformation | transformation part 42).

  In addition, the holding member 18 has a tubular portion 185 whose lumen communicates with the space of the narrow space portion 192. The tubular portion 185 is formed to protrude toward the distal end side at the central portion of the distal end portion of the holding member 18. When connecting the hub 52 of the sheath 5 and the holding member 18, the tubular portion 185 is inserted into the hub 52 from the hemostasis valve of the hub 52, and the narrow space portion 192 is inserted through the lumen of the tubular portion 185. The space communicates with the through hole 51 of the sheath 5.

  Further, the inner shape (the shape of the lumen) in the cross section of the distal end side of the narrow space portion 192 of the tubular portion 185 has a substantially square shape, and the holding member 18 has been moved to the proximal end side. At this time, the seal portion 41 (the direction of the width W1 shown in FIG. 3) of the clip 4 is substantially coincident with one diagonal line of the rectangle. Accordingly, the rotation of the seal portion 41 can be prevented when the clip 4 passes through the lumen of the tubular portion 185.

  The tubular portion 185 is configured such that the resistance (friction resistance) when the clip 4 passes through the lumen of the tubular portion 185 is larger than the resistance when the clip 4 passes through the narrow space portion 192. . Specifically, the tubular portion 185 (the distal end side member 18b) is set such that the length of the square diagonal line is set to be smaller than the width W1 of the seal portion 41, has flexibility, and can be deformed. It has become. As a result, when the seal portion 41 passes through the lumen of the tubular portion 185, an appropriate resistance (friction resistance) is developed, so that the deformed portion 42 of the clip 4 is surely connected to the opening 61 of the cover tube 6. Pushed into and held. Further, since the resistance is appropriate, it does not hinder the seal portion 41 from passing through the lumen of the tubular portion 185.

  When the holding member 18 moves to the proximal end side, the clip 4 in which the deformed portion 42 is held in the opening 61 of the cover tube 6 passes through the lumen of the tubular portion 185 and is discharged from the holding member 18. It is inserted into the through hole 51 of the sheath 5. In this case, since the clip 4 is inserted into the through hole 51 of the sheath 5 without contacting the hemostasis valve of the hub 52, the clip 4 is reliably inserted into the through hole 51 of the sheath 5 in a normal state. In this way, the state in which the clip 4 is housed in the housing portion 190 of the holding member 18 is changed to the state in which the deformed portion 42 of the clip 4 is held in the opening 61 of the cover tube 6.

  In addition, although it does not specifically limit as a constituent material of the holding member 18, For example, resin, a metal, etc. can be used. Moreover, in order to ensure internal visibility, what has optical transparency (substantially transparent or translucent) is preferable. Moreover, it is preferable to use a relatively soft resin material or the like so that the tubular portion 185 can be deformed.

  Next, the procedure of hemostasis work performed using the in vivo tissue closing apparatus 1 and the operation of the in vivo tissue closing apparatus 1 will be described.

  As shown in FIG. 15B, the sheath 5 is placed after treatment (PCI) or diagnosis (CAG) using a catheter, and this sheath 5 is used. The distal end of the sheath 5 penetrates the wound and is inserted into the blood vessel.

  As shown in FIG. 1 and FIG. 2, in the initial state, the lever 28 is positioned at the lock position, and the protrusion 291 of the lock portion 29 abuts on the tip side of the protrusion 346 of the slide connecting member 34. Is locked to the projecting portion 291, thereby preventing the slide connecting member 34 from moving in the distal direction.

  First, the operator (user) connects the holding member 18 of the placement device 3 to the hub 52 of the sheath 5. In this case, the tubular portion 185 of the holding member 18 is inserted into the hub 52 from the hemostasis valve of the hub 52, and the hub 52 is pushed inside the distal end portion of the holding member 18. Thereby, each rib 183 of the holding member 18 is inserted into the groove 54 of the hub 52 and engages with a surface in the groove 54. As a result, the holding member 18 and the hub 52 of the sheath 5 are connected and the state is held.

Next, the sheath 5 and the holding member 18 are moved along the cover tube 6 to the proximal end side.
As a result, the clip 4 comes into contact with the distal end of the opening 61 of the cover tube 6 and is locked (pressed toward the distal end) by the opening 61. Thereby, the seal part 41 of the clip 4 is gradually inclined along the inclined surface 194 (see FIG. 13).

  When the clip 4 is inserted into the narrow space portion 192, the radial load on the cover tube 6 applied to the deformed portion 42 increases, and the deformed portion 42 moves in the radial direction of the cover tube 6 more than in the initial state. 3 is compressed and extends in a direction substantially perpendicular to the seal portion 41 of the clip 4 in the basic shape shown in FIG. 3, and is reduced in a direction substantially parallel to the seal portion 41. Thereby, the clip 4 is completely folded.

  Further, when the seal portion 41 passes through the lumen of the tubular portion 185, an appropriate resistance is developed, whereby the deformed portion 42 of the clip 4 is pushed into the opening 61 of the cover tube 6 and held.

  The clip 4 in which the deformed portion 42 is held in the opening 61 of the cover tube 6 passes through the lumen of the tubular portion 185, is discharged from the holding member 18, and is inserted into the through hole 51 of the sheath 5. In this way, the state in which the clip 4 is housed in the housing portion 190 of the holding member 18 is changed to the state in which the deformed portion 42 of the clip 4 is held in the opening 61 of the cover tube 6.

  Further, the sheath 5 and the holding member 18 are moved to the base end side along the cover tube 6, and the holding member 18 is connected to the base portion 321 of the first charge member 32. In this case, the base end portion of the holding member 18 is pushed into the base portion 321. As a result, each claw 326 of the base 321 is inserted into the groove 184 of the holding member 18 and engages with a surface in the groove 184. As a result, the base portion 321 and the holding member 18 (hand portion 9) are connected, and the state is held. That is, the base 321 and the hub 52 are connected via the holding member 18 (the base 321, the holding member 18, and the hub 52 are integrated).

  Next, as shown in FIG. 15, the position of the tip of the elongated hole 313 of the inner tube portion 311 of the connector 31 and the position of the tip of the elongated hole 314 of the outer tube portion 312 match. The sheath 5, the holding member 18 and the first charge member 32 are pushed (moved) in the proximal direction, the base portion 321 of the first charge member 32 is inserted into the inner tube portion 311, and the protrusion 327 of the base portion 321 is inserted into the inner tube The long hole 313 of the part 311 and the long hole 314 of the outer pipe 312 are positioned at the front end of the long hole 313.

  At this time, the second charge member 33 is moved in the proximal direction together with the first charge member 32, whereby the coil spring 22 is sandwiched between the second charge member 33 and the thread support portion 15 and contracted (deformed or activated). Will be charged). Then, the pair of claws 335 of the second charge member 33 are engaged with the base portion 341 of the slide connecting member 34, and thereafter, the base end portion 325 of the pair of rod-like bodies 322 of the first charge member 32 is the casing. 11 is inserted into a pair of grooves 91 (see FIG. 2), the distance between the base end portions 325 of both rod-like bodies 322 is widened (see FIG. 2), and a pair of recesses 336 at the distal end portion of the second charge member 33. Then, the engagement with the pair of convex portions 323 of the first charge member 32 is released (see FIG. 2).

  As a result, the second charge member 33 cannot move with respect to the slide connecting member 34 and the thread support portion 15, the coil spring 22 is held in the contracted state (deformed state, active state), and the fixed tube 7 is It is held (substantially fixed) by the second charge member 33 and the slide connecting member 34 (the yarn support portion 15 is prevented from moving in the proximal direction with respect to the fixed tube 7). That is, the positional relationship among the second charge member 33, the slide connecting member 34, the thread support portion 15, the fixing tube 7, and the coil spring 22 is fixed, and these can move integrally. This state is called a charge state.

  In this state, the clip 4 (the seal portion 41 of the clip 4) is housed in the through hole (lumen) 51 of the sheath 5. For this reason, when the base portion 321 of the first charge member 32 is inserted into the inner tube portion 311 to be in a charged state, the clip 4 does not damage the blood vessel wall and is very safe.

  Next, as shown in FIG. 16, the outer tube portion 312 is rotated in a predetermined direction (in the illustrated example, counterclockwise when viewed from the distal direction). Accordingly, the projection 327 is pushed in the proximal direction by the edge facing the elongated hole 314 of the outer tube portion 312, and gradually moves in the proximal direction along the elongated hole 313 of the inner tube portion 311. The seal part 41 of the clip 4 and the cover tube 6 gradually protrude from the tip part of the clip 4. In this manner, the opening 61 of the cover tube 6 protrudes from the distal end portion of the sheath 5 and the seal portion 41 of the clip 4 protrudes and is inserted into the blood vessel, and the base portion 321 of the first charge member 32 is It moves in the proximal direction, and is further inserted into the inner tube 311 and fixed. Note that the base portion 321 of the first charge member 32 is prevented from moving in the proximal direction from the protrusion 93 when the base portion 321 contacts the pair of protrusions 93 of the casing 11. Further, since the engagement between the first charge member 32 and the second charge member 33 has already been released, the second charge member 33 does not move.

  Thus, in a state where the protrusion 327 of the base portion 321 of the first charge member 32 is positioned at the distal end portion of the elongated hole 313 of the inner tube portion 311 and the distal end portion of the elongated hole 314 of the outer tube portion 312, the clip 4 is Since the base portion 321 of the first charge member 32 is gradually moved in the base end direction by rotating the outer tube portion 312 from this state, the base portion 321 of the first charge member 32 is gradually moved in the base end direction. It is possible to reliably prevent the four seal portions 41 from protruding suddenly from the distal end of the sheath 5 toward the blood vessel wall.

  In addition, the swelling part 47 comes into contact with blood and starts to swell, but since the swelling speed is relatively slow, the volume of the swelling part 47 hardly changes until the placement of the clip 4 is completed. For this reason, the clip 4 can be placed in the target site easily and smoothly without obstructing the hemostasis operation.

  Next, the casing 11 of the hand portion 9 is gripped with fingers, and the hand portion 9, that is, the main body portion 2 (placement device 3) is slowly moved in one direction, that is, in the direction of pulling out from the wound (base end direction). The wound portion is covered with the seal portion 41 of the clip 4 from the inside of the blood vessel wall (positioning of the seal portion 41 is performed) (see FIG. 17B). The deformation part 42 of the clip 4 moves to the outside of the blood vessel.

  In the operation (operation) for covering the wound hole and the peripheral part of the wound hole with the seal portion 41, the surgeon moves the main body portion 2 in the direction of pulling out from the wound hole. When the resistance (surface contact resistance) at the time of contact with the surrounding tissue is sensed, it is determined that the seal portion 41 is in contact with the wound and the surrounding tissue (surface contact) and positioning of the seal portion 41 is completed. .

  In this case, among members that connect the clip 4, the thread support portion 15, and the casing 11 along the longitudinal direction of the placement device 3, a member that extends in the longitudinal direction of the placement device 3 such as a spring is included. Since the distance between the clip 4 and the casing 11 is kept substantially constant, the operator can directly detect the force applied to the seal portion 41 of the clip 4 with fingers, Thereby, it is possible to accurately sense the resistance when the seal portion 41 of the clip 4 comes into contact with the wound and the surrounding tissue.

  Further, since the lock portion 29 prevents the second charge member 33, the slide connecting member 34, the thread support portion 15, the fixed tube 7, and the coil springs 22 from moving in the distal direction, the positioning of the seal portion 41 is prevented. It is possible to reliably prevent the coil springs 22 from being activated before completion.

  Thereby, the sealing part 41 of the clip 4 can be positioned easily and reliably.

  Next, as shown in FIG. 17, the lever 28 is moved in the direction of the arrow b, and is positioned at the unlocking position. As a result, the lock portion 29 moves in the direction of the arrow b, and the protruding portion 291 moves (retracts) from the protrusion 346 of the slide connecting member 34 to the side (the position without the protrusion 346). The locking of the protrusion 346 is released. Accordingly, the second charge member 33, the slide connecting member 34, the thread support part 15, the fixed tube 7 and the coil springs 22 can move in the distal direction on condition that the stopper 35 releases the movement prevention state of the thread support part 15. become.

  Next, the main body 2 (arrangement device 3) is slowly moved in the direction (proximal direction) to be pulled out from the wound hole, and the main body 2 is pulled out from the wound hole. As a result, all the operations (operations) are sequentially performed in succession, the wound hole is closed by the clip 4, and the clip 4 is placed (indwelled) in the living body. Hereinafter, the procedure and operation at this time will be described in detail.

  First, as shown in FIG. 18, when the proximal portion 9 (casing 11) is moved in the proximal direction, the seal portion 41 of the clip 4 is in contact with the inner surface of the blood vessel wall (surface distal from the body surface). Therefore, the thread support portion 15 is pulled in the distal direction through the thread 8. When the force (pulling force) applied to the yarn support portion 15 via the yarn 8 exceeds a predetermined threshold value, the protrusion 172 of the pin 170 comes out of the gap of the stopper main body 351 of the stopper 35, and the second The charge member 33, the slide connecting member 34, the thread support portion 15, the fixed tube 7, and each coil spring 22 are integrally moved in the distal direction with respect to the casing 11.

  Here, in the positioning of the seal portion 41 in a state where the movement of the slide connecting member 34 in the distal direction is prevented by the lock portion 29, for example, the clip 4 is caught in the blood vessel, and the positioning is performed. Even if it is incomplete, it can be expected that the clip 4 comes off before the pin 170 comes out of the stopper 35 (the lock is released), and the clip 4 is moved to the flaw, and the seal portion 41 is moved to the flaw and its It can be brought into contact with surrounding tissue. Thus, since the positioning operation of the seal portion 41 of the clip 4 is performed twice, the seal portion 41 can be reliably brought into contact with the wound hole and the surrounding tissue.

  When the second charge member 33, the slide connecting member 34, the thread support portion 15, the fixed tube 7, and each coil spring 22 are moved in the distal direction with respect to the casing 11, the clip deforming portion 42 is moved together with the fixed tube 7. 6, the deformation portion 42 is detached from the distal end portion of the cover tube 6, and the deformation portion 42 can be deformed.

  Then, as shown in FIG. 19, when the base end portions 347 of the pair of rod-like bodies 342 of the slide connecting member 34 move until they are positioned in the hole portions 362 of the pair of rails 36, the base ends of the rod-like bodies 342 Each of the portions 347 can be moved (displaced) laterally (directions of arrows E and F). On the other hand, the slide connecting member 34 is urged in the distal direction with respect to the yarn support portion 15 by the restoring force of each coil spring 22, so that the base end portion 347 of each rod-like body 342 is urged by each urging force. It moves substantially laterally along the protrusion 155 and is inserted (retracted) into each hole 362, and the claw 343 of each rod-like body 342 is disengaged from each protrusion 155 of the thread support portion 15.

  As a result, the connection between the yarn support portion 15 and the second charge member 33 by the slide connection member 34 is released, and the yarn support portion 15 is proximal to the second charge member 33, the slide connection member 34 and the fixed tube 7. It is possible to move in the direction. Further, by releasing the connection between the thread support portion 15 and the second charge member 33 by the slide connection member 34, the relative relationship between the thread support portion 15 and the second charge member 33, the slide connection member 34, and the fixed tube 7. By making a general movement possible, the restriction for holding each coil spring 22 in a deformed state (active state) is released.

  As a result, the thread support portion 15 moves in the proximal direction with respect to the second charge member 33, the slide connecting member 34, and the fixed tube 7 by the restoring force of each coil spring 22. As described above, the slide connecting member 34, the pair of protrusions 155 of the yarn support portion 15, the pair of protrusions 334 of the second charge member 33, and the hole portions 362 of the pair of rails 36 activate each coil spring 22. It functions as a trigger means for activating each of the coil springs 22 by releasing the restriction held by the coil spring 22. Further, the slide connecting member 34, the pair of protrusions 155 of the thread support portion 15, and the pair of protrusions 334 of the second charge member 33 function as a restricting means for holding each coil spring 22 in an active state. Further, the base end portion 347 of each rod-shaped body 342 of the slide coupling member 34 that couples the thread support portion 15 and the second charge member 33 is laterally formed (the claw 343 of each rod-shaped body 342 is connected to each The operation (trigger operation) for moving in the direction away from the protrusion 155 is automatically performed by the operator pulling out (moving) the proximal portion 9 toward the proximal end and the urging force of each coil spring 22.

  When the yarn support portion 15 moves in the proximal direction with respect to the fixed tube 7, the yarn 8 moves in the proximal direction as shown in FIG. Pulled in the end direction, the knot 461 of the thread 46 of the clip 4 is locked to the tip 71 of the fixed tube 7, and the deformed portion 42 is locked (indirectly locked) via the knot 461. As a result, the knot 461 moves in the distal direction, the thread 46 is tightened, and the deforming portion 42 is deformed.

  As a result, the deformable portion 42 covers the wound hole and the peripheral portion of the wound hole from the outside of the blood vessel wall, and the seal portion 41 covers the wound hole and the peripheral portion of the wound hole from the inside of the blood vessel wall. 42, the blood vessel wall (wound hole) is sandwiched, and the wound hole is closed. The thread 46 holds (fixes) the deformed portion 42 in the above-described shape.

  Further, after the connection of the thread support portion 15 and the second charge member 33 by the slide connecting member 34 is released (regulation for holding each coil spring 22 in a deformed state), that is, the deformation of the deforming portion 42 of the clip 4 is performed. 20, when the proximal portion 9 (casing 11) is further moved in the proximal direction while the seal portion 41 of the clip 4 is in contact with the inner surface of the blood vessel wall, as shown in FIG. It further moves in the proximal direction relative to the yarn support 15. That is, the yarn support portion 15 further moves in the distal direction with respect to the casing 11.

  When the pin 170 provided on the thread support portion 15 moves until it is positioned on the tip side from the tip portion of the rib 92 of the casing 11, the pin 170 rotates at the step portion 921 and the projection 172 is prone. To do.

  As a result, the connection between the thread 8 and the thread support portion 15 by the pin 170 is released, and thereby the connection between the thread 8 and the thread 46 of the clip 4 is released (the holding state of the clip 4 by the thread 8 is released). ). That is, the folded portion 81 of the thread 8 is disengaged from the protrusion 172 of the pin 170, and the thread 8 can be extracted from the ring 462 of the thread 46 of the clip 4. Accordingly, the stepped portion 921 constitutes a connection releasing means and a holding state releasing means.

  Then, when the hand portion 9 (casing 11) is subsequently moved in the proximal direction, first, only the main body portion 2 (up to the distal ends of the sheath 5, the cover tube 6 and the fixed tube 7) is removed from the patient. At this stage, as shown in FIG. 20B, the folded portion 81 of the thread 8 is positioned outside the patient's body without coming off from the loop 462 of the thread 46 of the clip 4, and the clip 4 is held by the thread 8. ing.

  That is, in this in-vivo tissue closing device 1, the length of the thread 8 is set to be relatively long due to the structure and mechanism. Therefore, at the stage immediately after the main body 2 is removed from the patient, the folded portion 81 of the thread 8 Is not removed from the loop 462 of the thread 46 of the clip 4, the clip 4 is held by the thread 8, and the folded portion 81 of the thread 8 is located outside the patient's body. For this reason, the operator can hold (secure) the clip 4 via the thread 8 by grasping the main body part 2 and the folded part 81 of the thread 8, thereby It can respond to the situation and is very safe. In this case, for example, the operator can take out the clip 4 in the blood vessel by surgery while holding the clip 4 via the thread 8.

  If there is no problem, the hand 9 (casing 11) is further moved in the proximal direction as shown in FIG. 21, and the thread 8 is removed from the patient. Thereby, the clip 4 is arrange | positioned (indwelling) in the biological body.

  The swelling part 47 provided in the seal part 41 of the clip 4 is in contact with blood, and the swelling part 47 provided in the deformation part 42 is in contact with body fluid around the wound, so that each gradually swells. When a predetermined time elapses, it completely expands. Thereby, a wound hole can be closed reliably. Moreover, it can prevent that the seal | sticker part 41 falls outside from a wound hole, and the deformation | transformation part 42 slips out inside from a wound hole.

  As described above, according to the clip 4, when the clip 4 is placed at the target site, the clip 4 is easily and smoothly placed at the target site without being caught at an unfavorable location in the blood vessel. Can do.

  Further, the swelling of the swelling portion 47 increases the contact area of the seal portion 41 and the deformable portion 42 to the blood vessel wall, and the tightening force of the blood vessel wall by the seal portion 41 and the deformable portion 42 increases. Thus, the wound hole can be reliably closed and the seal portion 41 can be reliably fixed to the target site.

  Moreover, when the swelling part 47 swells, it can respond | correspond to the state (situation) of various blood vessels (in-vivo tissue membrane).

  As mentioned above, although the in-vivo tissue closure device of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is a thing of arbitrary structures which have the same function Can be substituted. In addition, any other component may be added to the present invention.

It is a perspective view showing an embodiment of an in-vivo tissue closure device. It is a disassembled perspective view (figure which shows each member (part)) of the arrangement | positioning apparatus of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view which shows embodiment of the in-vivo tissue closing device of this invention with which the in-vivo tissue closing device shown in FIG. 1 is provided. It is explanatory drawing which showed an example of the knot of the in-vivo tissue closure tool shown in FIG. It is explanatory drawing which showed the other example of the knot of the in-vivo tissue closure tool shown in FIG. It is sectional drawing in the AA line in FIG. 3 of the clip main body of the in-vivo tissue closure tool shown in FIG. It is sectional drawing in the BB line in FIG. 3 of the clip main body of the in-vivo tissue closure tool shown in FIG. It is sectional drawing in the CC line | wire in FIG. 3 of the clip main body of the in-vivo tissue closure tool shown in FIG. It is a figure which shows the thread | yarn support part, pin, and thread | yarn of the in-vivo tissue closure apparatus shown in FIG. It is sectional drawing which shows the base of the 1st charge member of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view which shows the holding member of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view which shows the base end side member and front end side member of a holding member shown in FIG. It is sectional drawing which shows the holding member shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Biological tissue closure apparatus 2 Main body part 3 Arrangement apparatus 4 Clip 40 Clip main body 41 Seal part 412 Plane part 42 Deformation part 421, 422 Corner | angular part 423 Upper surface 424 Inclined surface 425-428 Hole 429 Step part 44 Connection part 441 Hole 46 Yarn 461 Knot 462 Ring 47 Swelling part 5 Sheath 51 Through hole 52 Hub 53 Port part 54 Groove 6 Cover tube 61 Opening part 7 Fixed tube 71 Tip part 8 Thread 81 Folding part 9 Hand part 11 Casing 11a Upper cover 11b Lower cover 14 Cover tube Support portion 143 Hole portion 15 Thread support portion 150 Concave portion 155 Protrusion 156 to 158 Hole portion 170 Pin 171 Base portion 172 Protrusion 18 Holding member 18a Base end side member 18b Tip end side member 181 Protruding portion 182 Side hole 183 Rib 184 Groove 185 Tubular portion 186 Base End portion 187 Most proximal end portion 190 Storage portion 191 Wide space portion 1911 Widest space portion 1912 Near end space portion 192 Narrow space portion 193 Transition portion 194 Inclined surface 22 Coil spring 28 Lever 29 Lock portion 291 Protruding portion 31 Connector 311 Inner tube Portion 312 Outer tube portion 313, 314 Elongated hole 315 Rib 32 First charge member 321 Base portion 322 Bar-shaped body 323 Protruding portion 324 Hole portion 325 Base end portion 326 Claw 327 Projection 33 Second charge member 331-333 Hole portion 334 Protruding portion 335 Claw 336 Concave part 34 Slide connecting member 341 Base part 342 Rod-like body 343 Claw 344, 345 Hole part 346 Projection 347 Base end part 35 Stopper 351 Stopper main body 352 Support part 36 Rail 361 Groove 362 Hole part 37 Guide bar support part 38, 39 Guide bar support part 91 groove 9 Rib 921 stepped portion 93 projecting

Claims (20)

An in-vivo tissue closure device for closing a wound penetrating an in-vivo tissue membrane,
A plate-like seal portion covering the wound hole and the peripheral portion of the wound hole from one surface side of the in vivo tissue membrane;
A deformable portion that can be deformed into a shape that sandwiches the wound with the seal portion from the other surface side of the in vivo tissue membrane;
Holding means for holding the deforming portion in the shape;
A biological tissue closure device, wherein a swelling portion made of a material that swells in contact with a liquid is provided on at least a part of the outer surface of the biological tissue closure device.   The in vivo tissue closure device according to claim 1, wherein the swelling portion is provided in at least one of the seal portion and the deformation portion.   The in-vivo tissue closure device according to claim 1 or 2, wherein the swelling portion is provided on a surface and a side surface of the seal portion on the deformation portion side.   The deformed portion extends in a direction substantially perpendicular to the seal portion, and contracts in a direction substantially perpendicular to the seal portion, and a first shape reduced in a direction substantially parallel to the seal portion, The in-vivo tissue closure device according to any one of claims 1 to 3, which has a frame shape that is deformable between a second shape expanded in a direction substantially parallel to the seal portion.   The said swelling part is provided in the side surface of the site | part corresponding to the opposing surface with respect to the said seal part of this deformation | transformation part when the said deformation | transformation part becomes the said 2nd shape, and this opposing surface. In vivo tissue closure device.   The in vivo tissue closure device according to any one of claims 1 to 5, wherein the deformable portion has a pantograph-like shape.   The connection part which connects the said seal part and the said deformation | transformation part, and penetrates the said wound hole, The said swelling part is not provided in the outer surface of this connection part. In vivo tissue closure device.   The in-vivo tissue closure device according to any one of claims 1 to 7, wherein the swollen portion is obtained by applying and drying a solution containing a material constituting the swollen portion.   The in vivo tissue closure according to any one of claims 1 to 8, wherein the surface of the part forming the swollen part of the in vivo tissue closure device has higher hydrophilicity than the surface of the part not forming the swollen part. Ingredients.   The in-vivo tissue closure device according to any one of claims 1 to 9, wherein at least a surface of a site forming the swelling portion of the in-vivo tissue closure device is subjected to a hydrophilic treatment.   The in-vivo tissue closure device according to any one of claims 1 to 10, wherein at least a surface of a part forming the swelling portion of the in-vivo tissue closure device is subjected to a roughening treatment.   The in-vivo tissue closure device according to any one of claims 1 to 11, wherein the swelling portion is made of a gel polymer.   The in vivo tissue closure device according to claim 12, wherein the gel polymer has an anionic group in a part of its molecular structure and swells upon contact with a liquid that deprotonates the anionic group.   The in-vivo tissue closure device according to claim 12, wherein the gel polymer has a cationic group in a part of its molecular structure and swells upon contact with a liquid that protonates the cationic group.   The in vivo tissue closure device according to any one of claims 12 to 14, wherein the gel polymer includes at least one selected from acrylic acid, methacrylic acid and derivatives thereof as a monomer component.   The in vivo tissue closure device according to any one of claims 12 to 15, wherein the gel polymer contains an ethylenically unsaturated compound as a crosslinking agent.   The in vivo tissue closure device according to any one of claims 12 to 16, wherein the gel polymer swells upon contact with a liquid having a pH of 7.1 to 7.8.   The in vivo tissue closure device according to any one of claims 12 to 16, wherein the gel polymer swells upon contact with blood and body fluid around the wound.   The in-vivo tissue closure device according to any one of claims 12 to 18, wherein the gel polymer swells so that its volume becomes 3 to 5 times.   The in-vivo tissue closure device according to any one of claims 1 to 19, wherein each of the seal portion and the deformable portion is made of a bioabsorbable material.

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