JP5448533B2 - In vivo tissue closure device - Google Patents

Description

  The present invention relates to an in vivo tissue closing 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 easily and reliably perform such hemostasis work, various devices have been developed that are inserted through a wound on the surface of the skin and close the wound that penetrates the blood vessel wall (in vivo tissue membrane) ( For example, see Patent Document 1).

  The in-vivo tissue closure device of Patent Document 1 includes a wound hole penetrating a blood vessel wall (in-vivo tissue membrane) and an anchor that covers the periphery of the wound hole (the blood vessel wall around the wound hole) from the inside of the blood vessel, A closing device that closes the wound hole, and detachably holds the closing device, deforms the deformation portion, and closes the wound hole with the closing device. And a placement device to be placed on.

  When closing a wound hole in a blood vessel using this in-vivo tissue closing device, the distal end portion (closing tool) of the placement device is inserted into the blood vessel through a sheath inserted in the wound hole. Then, the placement device is slowly moved in the proximal direction. As a result, the anchor of the closure comes into contact with the wound hole and the periphery of the wound hole from the inside of the blood vessel wall, and the deformed portion moves to the outside of the blood vessel. In this positioning, when the operator moves the positioning device in the proximal direction and senses the resistance (surface contact resistance) when the anchor is in contact with the wound hole and its peripheral part, the anchor It is judged that the positioning of the anchor has been completed by contacting the peripheral portion.

  Next, after operating the lock lever to release the lock, when the placement device is slowly moved in the proximal direction, all operations (operations) are performed sequentially and continuously, and the deforming portion is deformed. Then, the wound is closed by the closing tool, and the closing tool is placed (indwelled) in the living body.

  However, when the vicinity of the wound hole in the blood vessel is calcified, for example, the deformed portion is not sufficiently deformed, and the wound hole may not be sufficiently closed.

Japanese Patent Application No. 2007-117716

  An object of the present invention is to provide an in vivo tissue closing device that can reliably close an undesirable hole penetrating an in vivo tissue membrane.

Such an object is achieved by the present invention of the following (1) to ( 11 ).
(1) An in vivo tissue closure device for closing an undesirable hole penetrating an in vivo tissue membrane,
An anchor that covers a peripheral portion of the hole from one surface side of the in vivo tissue membrane, a deformable deformable portion, and a closure that closes the hole;
An arrangement device that holds the closure detachably, performs an operation of deforming the deforming portion and closing the hole with the closure, and disposing the closure in a living body,
The placement device includes a detachment mechanism that detaches the closure when the placement device is moved in the proximal direction and removed from the living body, and a pressing unit that presses the deformation portion when the deformation portion is deformed. Have
The pressing means has a function of pressing the deforming portion to deform the deforming portion while being attached to the arranging device, and pressing the deforming portion in a state of being detached from the arranging device. And has a function of deforming
The in-vivo tissue closing device, wherein the detaching mechanism is configured to detach the pressing means together with the closing device from the placement device when the closing device is released.

(2) The placement device has a thread-like body that holds the closing tool at a distal end portion of the placement device,
The in-vivo tissue closing device according to (1), wherein the release mechanism releases at least one end of the filamentous body.

  (3) The raw mechanism according to (2), wherein the release mechanism is configured to release the proximal end side of the filamentous body in a state where the closure is held and to disengage the filamentous body together with the closure. Body tissue closure device.

  (4) The in-vivo tissue closing device according to (2) or (3), wherein the pressing unit is a tubular body that passes the filamentous body through a lumen.

  (5) The in-vivo tissue closing device according to (4), wherein the detachment mechanism includes an engagement member that engages with a proximal end portion of the tubular body and prevents movement of the tubular body in the proximal direction. .

  (6) The engagement member is larger than the lumen of the proximal end portion of the tubular body, and is fixed to the filamentous body on the proximal end side with respect to the proximal end portion of the tubular body. In vivo tissue closure device.

(7) The arrangement device has, on the base end side thereof, a thread support portion that supports the base end side of the filamentous body so as to be released,
The in-vivo tissue closing device according to any one of ( 4 ) to (6), wherein the closing tool is held on a distal end side of the filamentous body.

(8) The detachment mechanism includes a pin that is provided on the yarn support portion and can take an upright state and a prone state.
The in vivo tissue closing device according to (7), wherein a proximal end side of the filament is hung on the pin.

  (9) The in vivo tissue closing device according to (8), wherein the filament is wound around the pin and the closure.

(10) The placement device is detachably connected to the thread support portion, and a tubular body holding portion that detachably holds the tubular body;
An urging means for urging the yarn support portion in the proximal direction with respect to the tubular body;
A casing having a first part for raising the pin and a second part for lying down;
The casing is provided with a connection release part for releasing the connection between the thread support part and the tubular body holding part, and the thread support part and the tubular body holding part are movably installed,
When the casing is moved in the proximal direction in a state where the anchor of the closure is in contact with the peripheral portion of the hole, the connection between the thread support portion and the tubular body holding portion is released by the connection release portion. The urging means moves the yarn support portion in the proximal direction with respect to the tubular body, the deformation portion is pressed by the distal end portion of the tubular body, and the deformation portion is deformed,
When the casing is further moved in the proximal direction, the yarn support portion moves to the second part of the casing with respect to the casing, the pin falls down, and the proximal end side of the filamentous body is separated from the pin. The in-vivo tissue closure device according to (8) or (9), which is configured to be released.
(11) The placement device has an opening that can hold the deformed portion of the closure at the tip, and a long portion that can penetrate the hole;
A holding member that holds the closure and a part or all of which is movable with respect to the elongated portion;
A part or all of the holding member moves to the proximal end side with respect to the elongated portion. At this time, the deformed portion of the closing tool is moved from the state where the closing tool is held by the holding member. The in-vivo tissue closing device according to any one of (1) to (10), wherein the in-vivo tissue closing device is configured to be held at a distal end portion of a long portion.

  According to the present invention, when the closure device is detached from the placement device, the pressing means is detached from the placement device together with the closure device, so that the deformed portion is not sufficiently deformed, and an undesirable hole penetrating the in vivo tissue membrane is formed. If not sufficiently closed, the pressing means can be used to securely close the hole.

It is a perspective view which shows embodiment of the in-vivo tissue closure apparatus of this invention. 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 the closure tool of the in-vivo tissue closure apparatus shown in FIG. It is explanatory drawing which showed an example of the knot of the closing tool of the in-vivo tissue closure apparatus shown in FIG. It is explanatory drawing which showed the other example of the knot of the closure tool of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view 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 the 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. It is sectional drawing which shows the thread | yarn support part, pin, slide connection member, fixing tube, thread | yarn, and stopper of the in-vivo tissue closure apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closure apparatus shown in FIG. It is a perspective view for demonstrating operation which deform | transforms a deformation | transformation part by hand using the fixed tube and thread | yarn of the in-vivo tissue closure apparatus shown in FIG. 1, and closes a wound.

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

  FIG. 1 is a perspective view showing an embodiment of the in-vivo tissue closing device of the present invention, and FIG. 2 is an exploded perspective view of the arrangement device for the in-vivo tissue closing device shown in FIG. 1 (showing each member (part)). 3 is a perspective view showing a closure of the in-vivo tissue closing device shown in FIG. 1, FIG. 4 is an explanatory view showing an example of a knot of the closing device of the in-vivo tissue closing device shown in FIG. FIG. 6 is an explanatory view showing another example of the knot of the closure of the in-vivo tissue closing device shown in FIG. 1, and FIG. 6 is a perspective view showing a thread support portion, a pin and a thread of the in-vivo tissue closing device shown in FIG. 7 is a cross-sectional view showing a base portion of a first charge member of the in-vivo tissue closing device shown in FIG. 1, FIG. 8 is a perspective view showing a holding member of the in-vivo tissue closing device shown in FIG. FIG. 10 is a perspective view showing the proximal end member and the distal end side member of the holding member shown in FIG. 8, and FIG. 10 is a cross-sectional view showing the holding member shown in FIG. A. FIGS. 11 to 18 are perspective views for explaining the operation (operation) of the in-vivo tissue closing device shown in FIG. 1, respectively, and FIGS. (B) shows the tip side. 19 is a cross-sectional view showing a thread support portion, a pin, a slide connecting member, a fixing tube, a thread, and a stopper of the in-vivo tissue closing device shown in FIG. 1, and FIGS. FIG. 22 is a cross-sectional view for explaining the action (operation) of the in-vivo tissue closing device shown in FIG. 22, and FIG. 22 shows a deformed portion manually deformed using the fixing tube and thread of the in-vivo tissue closing device shown in FIG. It is a perspective view for demonstrating operation which closes a wound hole.

  In FIGS. 1 and 12 to 18, the upper cover of the casing is not shown, and the inside of the rail on one side (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. 10, a cover tube and a fixed tube are each shown with a broken line, and in FIG.11 (c), a fixed tube is shown with a broken line.

  Also, in FIGS. 12 to 18, the illustration of the yarn is omitted except for a part in order to prevent the drawings from becoming complicated. In FIGS. 20 and 21, the main part is illustrated.

  For convenience of explanation, in FIGS. 1, 2, 7 to 10, and 12 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 5 and FIG. 11, 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, an in-vivo internal organ, or an in-vivo internal tissue. It is a device that closes (closes) an undesirable hole through the body tissue membrane. Hereinafter, the undesired holes are referred to as “scratches”.

  As shown in FIGS. 1, 2, and 3, the in-vivo tissue closing device 1 is a long body having a distal end portion capable of penetrating a wound hole penetrating the in-vivo tissue membrane and having a proximal portion 9 on the proximal end side. A disposing device (transfer / deformation means) 3 and a closing device (in vivo tissue closing device) that is detachably held (connected) at the distal end portion of the arranging device 3 and closes a wound hole that penetrates the in vivo tissue membrane. A clip 4 is provided.

  The clip 4 includes a clip main body (closure main body) 40 and a thread (first thread-like body) 46 that is a fixing portion. The clip main body 40 includes an anchor 41, a deformable deformable portion 42, and an anchor. 41 and a connecting portion 44 that connects the deformable portion 42. 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 (elongated tube) 5 having a through hole (lumen) 51 penetrating the wound hole in the axial direction in the center, that is, in the sheath 5. It is used by being detachably attached (the sheath 5 is detachably attached to the placement device 3) (see FIG. 13). The sheath 5 and the placement device 3 constitute a long main body 2. Further, at the time of hemostasis work (work for closing a wound hole), the sheath 5 and the distal end portion of the placement device 3 and the clip 4 respectively penetrate the wound hole. That is, it is inserted into a living body lumen (biological lumen) such as a blood vessel from a wound hole.

  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 includes a thread (second thread-like body) 8 that holds the clip 4 (the thread 46 of the clip 4) at the tip thereof, and a long first tubular member whose tip can penetrate the wound hole. Cover tube (cover member) (cover means) 6 which is (long portion) and fixed tube (locking member) which is a long second tubular member (tubular body) whose tip portion can penetrate the wound hole ) (Pressing means) 7 and positioned in the distal end of the cover tube 6 in the initial state (immediately after assembly), accommodates (holds) the clip 4, and is proximal (in the proximal direction) along the cover tube 6 A holding member (inserter) 18 that can be moved to the right side, 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. The thread 8 has a portion of the clip 4 on the side opposite to the anchor 41 of the deformed portion 42 (the distal end side) relative to the portion of the deformed portion 42 on the anchor 41 side (base portion side) (base end side). The clip 4 is held so that it can move (displace).

  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 cross-sectional shape of the fixed tube 7 is such that the distal end 71 can lock a knot 461 of the thread 46 of the clip 4 described later (the knot 461 does not enter the lumen), and the holding member 18 described later As a shape that does not rotate, for example, a substantially oval shape (a shape in which a circle is crushed) is formed, and a portion closer to the base end side is substantially circular.

  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. The shape of the cover tube 6 in the cross section is, for example, a substantially elliptical shape (a shape in which a circle is crushed) as a shape that can easily hold the deformed portion 42 at the distal end, that is, the opening 61. The proximal proximal portion (the portion corresponding to the distal end portion 71 of the fixed tube 7) is deformed into a shape corresponding to the distal end portion 71 of the fixed tube 7, that is, an approximately elliptical shape. The proximal end portion is substantially circular.

  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, the fixing tube 7 has a function of pressing the deforming portion 42 when the deforming portion 42 of the clip 4 is deformed, that is, when the thread 46 of the clip 4 is pulled in the proximal direction by the thread 8. The knot 461 of the thread 46 of the clip 4 is locked to the leading end 71 of the clip 4, and the deformed portion 42 is locked (indirectly locked) via the knot 461, whereby the knot 461 is relatively moved. By moving in the distal direction, the thread 46 is tightened and the deforming portion 42 is deformed.

  As shown in FIGS. 1, 2, and 19, 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 yarn that supports the yarn 8. A support portion (holding member support portion) 15, a pin (connecting means) 170 that is rotatably installed on the yarn support portion 15 and removably connects the yarn 8 to the yarn support portion 15; The second charge member 33, the thread support portion 15 and the second charge member 33 are detachably connected (removably connected to the thread support portion 15), the slide connection member (connection means) 34, and the biasing means. A pair of coil springs (elastic members) (a driving member) 22, 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 have. 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 provided on the inner side of the lower cover 11b as a first portion that puts the pin 170 in an upright state on the arrangement device 3 (casing 11). A stepped portion 921 is formed on the distal end side of the distal end portion of the rib 92 as a second portion that causes the pin 170 to fall down (FIGS. 2 and 20). FIG. 21).

  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. The inner diameter of the hole 345 is set to be smaller on the base end side than on the tip end side, whereby a step 348 is formed in the hole 345.

  The base end portion of the fixed tube 7 is detachably fitted (held) in the hole portion 345 of the base portion 341 of the slide connecting member 34. In this case, the base end portion of the fixed tube 7 engages with the stepped portion 348, and the movement of the fixed tube 7 in the base end direction with respect to the slide connecting member 34 is prevented, whereby the deformed portion 42 and the knot of the clip 4 are prevented. 461 can be reliably pressed. Thus, the slide connecting member 34 has a function as a tubular body holding portion that detachably holds the fixed tube 7.

  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 to 6, protrusions 155 that engage with the corresponding claws 343 of the slide connecting member 34 are formed on both sides of the tip 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 hole 157 through which the thread 8 is inserted is formed at the tip of the thread support section 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 (held) on the guide bar support 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 yarn support portion 15 (the yarn 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 contracted (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 somewhat caught in the blood vessel or the like before the anchor 41 of the clip 4 is surely brought into contact with the wound hole and the surrounding tissue, the pin 170 is removed from the stopper 35 (the lock is released). The clip 4 can be expected to come off before, and the clip 4 can be moved to the wound and the anchor 41 can be brought into contact with the wound and the surrounding tissue. In addition, the pin 170 can be expected to come off from the stopper 35 (the lock is released) before the clip 4 and the surrounding tissue are excessively pulled in the proximal direction by the clip 4, and the anchor can be safely and reliably 41 can be brought into contact with the wound and the surrounding tissue.

  As shown in FIGS. 6 and 19, the thread 8 is a thread (thread-like body) formed as a ring, and the loops 462 of the thread 46 of the clip 4 are inserted and both ends thereof are tied. . As a result, the clip 4 is held at the tip end portion 82 (tip end side) of the yarn 8. Then, the thread 8 is inserted through the fixing tube 7, further through the hole 157 of the thread support portion 15, and its base end portion 81 (base end side) is hooked on the protrusion 172 of the pin 170. As a result, the base end portion 81 of the yarn 8 is detachably supported by the yarn support portion 15 via the pin 170 (so that it can be released).

  In this way, the thread 8 is wound around the protrusion 172 of the pin 170 and the ring 462 of the thread 46 of the clip 4.

  Further, a stopper (bulk member) 121 is fixed in the middle of the yarn 8 as an engaging member that engages with the proximal end portion of the fixed tube 7 and prevents the fixed tube 7 from moving in the proximal direction. . The stopper 121 is attached to the yarn 8 between the base end side of the fixed tube 7, that is, between the base portion 341 of the slide connecting member 34 (base end portion of the fixed tube 7) and the yarn support portion 15. It is fixed. Note that the stopper 121 is fixed to two of the yarns 8 in a state where the yarn 8 is doubled (ring).

  Further, the size of the stopper 121 is larger than the lumen of the proximal end portion of the fixed tube 7 and smaller than the hole portion 345 of the slide connecting member 34. In the illustrated configuration, the stopper 121 has a spherical shape, and the diameter thereof is set to be larger than the diameter of the lumen of the proximal end portion of the fixed tube 7 and smaller than the diameter of the hole portion 345. Accordingly, the stopper 121 can pass through the hole 345 and can be engaged (contacted) with the proximal end portion of the fixed tube 7.

  In addition, although the thread | yarn 8 is single in this embodiment, it is not restricted to this, You may be double or more.

  Further, the yarn 8 may not be a ring. Specifically, for example, the front end side of the thread 8 may be tied to the ring 462 of the thread 46 of the clip 4, and a ring that passes through the ring 462 of the thread 46 is formed on the front end side of the thread 8. May be. Further, a ring that is hooked on the protrusion 172 of the pin 170 may be formed on the proximal end side of the thread 8.

  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.

  As shown in FIG. 7, 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 detachably fitted to the base portion 341 of the slide connecting member 34 as described above.

  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. 12 and 13, 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 (closing tool) 4 has a clip body (closing tool body) 40 and a thread (first thread-like body) 46 that is a fixing portion.

  The clip body 40 includes an anchor 41, a deformable deformable portion 42, and a connection portion 44 that connects the anchor 41 and the deformable portion 42. It is preferable that the anchor 41, the deforming portion 42, and the connecting portion 44, that is, the clip main body 40 are integrally formed of the same material.

  The anchor 41 is a flat surface portion that is in close contact with the peripheral portion of the wound hole (the portion including the wound hole of the biological tissue film) from one surface (inner surface) side of the biological tissue membrane and covers the wound hole and the peripheral portion of the wound hole. (Plane) 412 is a member having a plate shape.

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

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

  That is, the deformed portion 42 extends in a direction substantially perpendicular to the anchor 41 and contracts in a direction substantially perpendicular to the anchor 41, and the first form in which the deformed portion 42 contracts in a direction substantially parallel to the anchor 41. 41 is in the shape of a frame that can be deformed between the second shape expanded in a direction substantially parallel to 41. Therefore, the deforming portion 42 is changed from the basic form (basic shape) (natural state) shown in FIG. 3 to the form that can pass through the wound or the anchor 41 from the other surface (outer surface) side of the in vivo tissue membrane. It can be deformed into any form between the first form and the second form, such as a form in which a tissue membrane can be sandwiched and a wound can be closed.

  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. Then, of the two corner portions 421 and 422 at the diagonal positions in the vertical direction in FIG. 3, the lower corner portion 422 in FIG. 3 (anchor 41 side) is a flat portion of the anchor 41 via the connection portion 44. 412 is connected to substantially the center, and is a non-movable portion that cannot move with respect to the upper end of the connecting portion 44 in FIG.

  As a result, 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 be expanded and contracted in two orthogonal directions, and can swing with respect to the anchor 41. You can also.

  Moreover, the upper surface (surface on the opposite side to the anchor 41) 423 of the upper side (the side opposite to the anchor 41) 423 in FIG. 3 of the two corners 421 and 422 forms a curved convex surface. Two holes (through holes) 425 and 428 are formed near the center of the corner portion 421 of the deformable portion 42 (the end portion of the deformable portion 42 opposite to the anchor 41), and near the center 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 anchor 41 can be tilted (laid down) more greatly, 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 anchor 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 anchor 41 and the end of the deformable portion 42 on the anchor 41 side, and is attached to the clip body 40. In the present embodiment, the thread 46 penetrates the corner portion 421 of the deformable portion 42 (the end portion of the deformable portion 42 opposite to the anchor 41) and the connection portion 44, and the corner portion 421 of the deformable portion 42 and the connection portion. 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 deform | transform into the predetermined | prescribed form between a 1st form and the said 2nd form, and can maintain the state. When the thread 46 holds the deformed portion 42 in the predetermined form, the knot 461 is located at the end of the deformable portion 42 opposite to the anchor 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 fixing part of the deforming part 42.

  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.

  It is preferable that at least a part of the clip body 40 of the clip 4 is made of a bioabsorbable material. In particular, the main part (most part) of the clip body 40 is integrally made of the bioabsorbable material. Preferably it is done. Thereby, since the main part of 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 resin and a metal, 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. 11, 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 has a direction (cover) that is substantially perpendicular to the anchor 41 as shown in FIG. The tube 6 extends in the longitudinal direction (axial direction) and is reduced in a direction substantially parallel to the anchor 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. 11, and the deformable portion 42 is shown in FIG. The form is continuously deformed from the form shown in FIG. 11 (b) and the form shown in FIG. 11 (c), in which the in vivo tissue membrane can be sandwiched between the anchor 41 and the deforming part 42 and the wound can be closed. To do. That is, the deforming portion 42 contracts in a direction substantially perpendicular to the anchor 41 (longitudinal direction of the cover tube 6) and expands in a direction substantially parallel to the anchor 41 (radial direction of the cover tube 6).

  In addition, as described above, the knot 461 is knotted so that it can move in the distal direction only when a strong force is applied, so that the thread 46 keeps the deformed portion 42 in a predetermined form. 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, the deformed portion 42 can be maintained in a desired state. 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 (closing tool) is not limited to the above as long as it has an anchor and a deformed portion.

  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 fixing portion of the clip is not limited to the filamentous body.

Next, the holding member 18 will be described.
As shown in FIGS. 8 to 10, 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. 8 and 10, 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 anchor 41 is housed in the widest space portion 1911 of the transition portion 193 and 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 oriented in a direction perpendicular to the paper surface of FIG. 10, and the other pair of sides is oriented in the vertical direction in FIG. As a result, the clip 4 is stored in such a posture that the direction of the width W shown in FIG. 3 of the anchor 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) on the base end side from the wide space portion 191 of the holding member 18 is to hold the deformed portion 42 in the collapsed state. It has a suitable shape (for example, 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. 10 (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 anchor 41 of the clip 4 is gradually inclined along the inclined surface 194.

  On the other hand, the upper surface in FIG. 10 of the transition part 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 form shown in FIG. 4 extends in a direction substantially perpendicular to the anchor 41 (longitudinal direction of the cover tube 6) and contracts in a direction substantially parallel to the anchor 41 (radial direction of the cover tube 6) (FIG. 11A). Reference). 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.13 (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 anchor 41 (the direction of the width W shown in FIG. 3) of the clip 4 is substantially coincident with one diagonal line of the rectangle. Thereby, when the clip 4 passes through the lumen of the tubular portion 185, the rotation of the anchor 41 can be prevented.

  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 smaller than the width W of the anchor 41, has flexibility, and can be deformed. ing. As a result, when the anchor 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 can be surely connected to the opening 61 of the cover tube 6. Pushed and held. Further, since the resistance is appropriate, the anchor 41 is not hindered 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. 12B, the sheath 5 is indwelled after treatment (PCI) or diagnosis (CAG) using a catheter, and this sheath 5 is used. The distal end portion of the sheath 5 penetrates the wound hole 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. As a result, the anchor 41 of the clip 4 is gradually inclined along the inclined surface 194 (see FIG. 10).

  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. Compressed and extended in a direction substantially perpendicular to the anchor 41 of the clip 4 in the basic form shown in FIG. 3 and reduced in a direction substantially parallel to the anchor 41. Thereby, the clip 4 is completely folded.

  Further, when the anchor 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. 12, 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 distal end of the elongated hole 314 of the outer tube portion 312 are matched. 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 becomes immovable with respect to the slide connecting member 34 and the thread support portion 15, and the coil spring 22 is held in the contracted state (deformed state, active state) (the thread support portion 15 is fixed). It is prevented from moving in the proximal direction with respect to the 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 (anchor 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. 13, the outer tube portion 312 is rotated in a predetermined direction (in the illustrated example, counterclockwise when viewed from the distal end 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 anchor 41 and the cover tube 6 of the clip 4 gradually protrude from the distal end portion. In this manner, the opening 61 of the cover tube 6 protrudes from the distal end portion of the sheath 5, the anchor 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 the base portion 321. It moves in the end direction, and is further inserted into the inner tube portion 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 anchors 41 from suddenly projecting from the distal end of the sheath 5 toward the blood vessel wall.

  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 hole (base end direction). The wound hole and the peripheral part of the wound hole are covered from the inside of the blood vessel wall with the anchor 41 of the clip 4 (the anchor 41 is positioned) (see FIG. 14B). The deformation part 42 of the clip 4 moves to the outside of the blood vessel.

  In the operation (operation) when the surgeon covers the wound hole and the peripheral portion of the wound with the anchor 41, the anchor 41 is moved to the direction in which the main body 2 is pulled out from the wound hole. When the resistance (surface contact resistance) at the time of contact with the tissue is sensed, it is determined that the anchor 41 is contacted (surface contacted) with the wound and the surrounding tissue, and positioning of the anchor 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 surgeon can directly detect the force applied to the anchor 41 of the clip 4 with fingers. Thus, it is possible to accurately sense the resistance when the anchor 41 of the clip 4 comes into contact with the wound hole and the surrounding tissue.

  In addition, 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, so that the positioning of the anchor 41 is completed. It is possible to reliably prevent the coil springs 22 from being activated before the operation.

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

  Next, as shown in FIG. 14, 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) (casing 11) is slowly moved in the direction of pulling out from the flawed hole (base end direction), and the main body 2 is pulled out of the flawed hole. As a result, all the operations (operations) are sequentially and continuously performed, 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. 15, when the proximal portion 9 (casing 11) is moved in the proximal direction, the anchor 41 of the clip 4 is moved to the wound hole and the peripheral portion of the wound hole, that is, the inner surface of the blood vessel wall (body surface). The thread support portion 15 is pulled in the distal direction via 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 projection 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 anchor 41 in a state in which 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 unsatisfactory. Even if it is complete, it can be expected that the clip 4 comes off before the pin 170 comes out of the stopper 35 (the lock is released), the clip 4 is moved to the wound hole, and the anchor 41 is moved to the wound hole and its surrounding tissue. It can be made to contact. Thus, since the positioning operation of the anchor 41 of the clip 4 is performed twice, the anchor 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. 16, 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 thread support portion 15 and the second charge member 33 by the slide connection member 34 (the connection between the slide connection member 34 and the thread support portion 15) is released, and the thread support portion 15 is connected to the second charge member 33. It is possible to move in the proximal direction with respect to the slide connecting member 34 and the fixed tube 7. 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. In addition, the main part of a connection cancellation | release part is comprised by the hole 362 of each rail 36. FIG.

  Thereby, 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 (biasing 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 thread support portion 15). 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 deformed portion 42 of the clip 4 is pressed and deformed by the distal end portion 71 of the fixed tube 7 as shown in FIG. That is, the thread 8 moves in the proximal direction, and the thread 46 of the clip 4 is pulled in the proximal direction by the thread 8, and the knot 461 of the thread 46 of the clip 4 is locked to the distal end portion 71 of the fixing tube 7. Further, the deformable portion 42 is locked (indirectly locked) through the knot 461, whereby the knot 461 moves in the distal direction, the thread 46 is tightened, and the deformable portion 42 is deformed.

  As a result, the deformed portion 42 covers the wound hole and the peripheral portion of the wound hole from the outside of the blood vessel wall, and the anchor 41 covers the wound hole and the peripheral portion of the wound hole from the inside of the blood vessel wall. The blood vessel wall is pinched and the wound is closed. Then, the thread 46 holds (fixes) the deformed portion 42 in the state described above.

  Drive that performs an operation of deforming the deforming portion 42 by the thread support portion 15, the pin 170, the stopper 35, the first charge member 32, the second charge member 33, the slide connecting member 34, each coil spring 22, and each guide bar 37. The main part of the mechanism is constructed.

  Further, the pin 170, the stepped portion 921, and the stopper 121 constitute a main part of a detaching mechanism that detaches the clip 4 when the main body 2 (arrangement device 3) is moved in the proximal direction to be removed from the living body.

  Further, after the connection between 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 is released), that is, the deformation portion 42 of the clip 4 After the deformation is completed, as shown in FIG. 17, when the proximal portion 9 (casing 11) is further moved in the proximal direction in a state where the anchor 41 of the clip 4 is in contact with the inner surface of the blood vessel wall, the casing 11 is 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.

  Then, as shown in FIGS. 20 and 21, when the pin 170 provided on the thread support portion 15 moves to the tip side of the rib 92 of the casing 11 (up to the step portion 921), a step is formed. The pin 170 rotates at the portion 921 and the projection 172 falls down.

  Thereby, the connection between the yarn 8 and the yarn support portion 15 by the pin 170 is released, that is, the base end portion 81 of the yarn 8 is released (disengaged) from the pin 170. A clip 4 is held at the tip of the thread 8.

  Subsequently, when the proximal portion 9 (casing 11) is moved in the proximal direction, the stopper 121 enters the hole 345 of the slide connecting member 34 as shown in FIG. Accordingly, the movement of the fixed tube 7 in the proximal direction is prevented. Thereby, the fitting of the proximal end portion of the fixed tube 7 to the slide connecting member 34 is released, and the fixed tube 7 is detached from the placement device 3. That is, the fixed tube 7, the thread 8, the stopper 121 and the clip 4 are all detached from the placement device 3, and the main body 2 from which they are detached is removed from the patient.

  Here, whether or not the wound has been sufficiently closed by the clip 4 can be confirmed based on the presence or absence of blood outflow (back flush) from the proximal end portion of the fixed tube 7. That is, when the wound hole is sufficiently closed by the clip 4, the blood does not flow out from the proximal end portion of the fixed tube 7, but the deformed portion 42 of the clip 4 is not sufficiently deformed, for example, by the clip 4. When the wound is not sufficiently closed (for example, when the vicinity of the wound in the blood vessel is calcified), the deformed portion 42 is located in the blood vessel. Is deformed (when intravascular deployment occurs), blood flows out from the proximal end portion of the fixed tube 7.

  When the surgeon confirms that blood does not flow out from the proximal end portion of the fixed tube 7, the thread 8 is cut by the operator's procedure, the thread 8 and the stopper 121 are removed, and the fixed tube 7 is removed, and the clip 4 is placed (indwelled) in the living body as shown in FIG.

  On the other hand, when the outflow of blood from the proximal end portion of the fixed tube 7 is confirmed, when the deformed portion 42 is not sufficiently deformed and the wound hole is not sufficiently closed by the clip 4, the fixed tube 7 and the thread 8 Then, the deforming portion 42 is deformed again manually and the wound hole is closed with the clip 4.

  That is, as shown in FIG. 22, the fixed tube 7 is pressed (or slightly pressed toward the distal end), and the deformed portion 42 of the clip 4 is pressed by the distal end portion 71 of the fixed tube 7, while the thread 8 is moved in the proximal direction. pull. As a result, the knot 461 of the clip 4 moves in the distal direction, the thread 46 is tightened, and the deforming portion 42 is reliably and sufficiently deformed. Then, when the wound hole is sufficiently closed by the clip 4, the outflow of blood from the proximal end portion of the fixed tube 7 stops.

  Next, the thread 8 is cut by the operator's procedure, the thread 8 and the stopper 121 are removed, and the fixing tube 7 is removed. As shown in FIG. 18, the clip 4 is placed in the living body ( Detained).

  Even when the deformed portion 42 is located in the blood vessel and the deformed portion 42 has been deformed, the clip 4 is held by the distal end portion 82 of the thread 8, so that the operator Without losing sight of the clip 4 in the blood vessel, the next treatment (for example, removal by surgery) can be performed. For this reason, safety is very high. Further, by providing a marker having contrast properties such as X-ray contrast property at the distal end portion 71 of the fixed tube 7, the position of the distal end portion 71 of the fixed tube 7 can be specified under contrast (under fluoroscopy). Thereby, the position of the clip located in the vicinity of the front end portion 71 can be specified.

  As described above, according to the in-vivo tissue closing device 1, all operations (operations) are performed by the operator only by moving the proximal portion 9 (casing 11) in the proximal direction (one direction). This is performed without the need for the above operation, the wound hole is closed by the clip 4, and the clip 4 can be placed (indwelled) in the living body. For this reason, it can be easily operated with one hand, and hemostasis can be easily, quickly and reliably performed on a wound formed in a tissue membrane in a living body such as a blood vessel wall. That is, the wound can be closed (closed) easily, quickly and reliably.

  In particular, since the deforming portion 42 of the clip 4 is deformed by the restoring force of the coil spring 22, the operator does not need to perform an operation of manually deforming the deforming portion 42 of the clip 4, and always has a constant tightening force. And the flaw hole can be closed very easily, quickly and reliably.

  And when the deformation | transformation part 42 of the clip 4 does not fully deform | transform and a wound hole is not fully closed, the deformation | transformation part 42 is manually performed using the fixed tube 7 and the thread | yarn 8 which removed from the main-body part 2. FIG. Thus, the wound hole can be reliably closed by the clip 4.

  Further, the state of the deformed portion 42 of the clip 4 can be held by the thread 46 in a state in which the deformed portion 42 is in a desired form between the first form and the second form. Thereby, it can respond to the state (situation) of various in-vivo tissue membranes.

  As mentioned above, although the in-vivo tissue closing 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.

  In the present invention, even if the release of the restriction (trigger means) for holding the coil spring (first elastic member) 22 in the deformed state (active state) is performed by operating a switch or a button, for example. Good.

DESCRIPTION OF SYMBOLS 1 Biological tissue closure apparatus 2 Main body part 3 Arrangement apparatus 4 Clip 40 Clip main body 41 Anchor 412 Plane part 42 Deformation part 421, 422 Corner | angular part 423 Upper surface 425-428 Hole 429 Step part 44 Connection part 441 Hole 46 Yarn 461 Knot 462 Ring 5 sheath 51 through-hole 52 hub 53 port part 54 groove 6 cover tube 61 opening 7 fixed tube 71 tip 8 thread 81 base end 82 tip 9 hand 11 casing 11a upper cover 11b lower cover 121 stopper 14 cover tube support Portion 143 Hole portion 15 Thread support portion 150 Recess portion 155 Protrusion 157, 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 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 Protrusion 347 Base end part 348 Step part 35 Stopper 351 Stopper body 352 Support part 36 Rail 361 Groove 362 Hole part 37 Guide bar 38 Bar support Part 91 groove 92 rib 921 stepped portion 93 projecting

Claims (11)

An in vivo tissue closure device for closing an undesirable hole penetrating an in vivo tissue membrane,
An anchor that covers a peripheral portion of the hole from one surface side of the in vivo tissue membrane, a deformable deformable portion, and a closure that closes the hole;
An arrangement device that holds the closure detachably, performs an operation of deforming the deforming portion and closing the hole with the closure, and disposing the closure in a living body,
The placement device includes a detachment mechanism that detaches the closure when the placement device is moved in the proximal direction and removed from the living body, and a pressing unit that presses the deformation portion when the deformation portion is deformed. Have
The pressing means has a function of pressing the deforming portion to deform the deforming portion while being attached to the arranging device, and pressing the deforming portion in a state of being detached from the arranging device. And has a function of deforming
The in-vivo tissue closing device, wherein the detaching mechanism is configured to detach the pressing means together with the closing device from the placement device when the closing device is released. The placement device has a thread-like body that holds the closure at the tip of the placement device,
The in-vivo tissue closing device according to claim 1, wherein the detachment mechanism releases at least one end side of the filamentous body.   The in-vivo tissue closing device according to claim 2, wherein the detachment mechanism is configured to release a proximal end side of the filamentous body in a state where the closure is held, and to disengage the filament together with the closure. .   The in-vivo tissue closing device according to claim 2 or 3, wherein the pressing means is a tubular body in which the filamentous body is passed through a lumen.   The in-vivo tissue closing device according to claim 4, wherein the detachment mechanism has an engagement member that engages with a proximal end portion of the tubular body and prevents movement of the tubular body in the proximal direction.   The in-vivo tissue according to claim 5, wherein the engaging member is larger than a lumen of a proximal end portion of the tubular body and is fixed to the filamentous body on a proximal end side with respect to the proximal end portion of the tubular body. Closure device. The arrangement device has, on the base end side thereof, a thread support portion that supports the base end side of the filamentous body so as to be released,
The in-vivo tissue closing device according to any one of claims 4 to 6, wherein the closing tool is held on a distal end side of the filamentous body. The detachment mechanism is provided on the thread support portion, and has a pin that can take an upright state and a prone state.
The in vivo tissue closing device according to claim 7, wherein a proximal end side of the filament is hung on the pin.   The in vivo tissue closing device according to claim 8, wherein the filament is wound around the pin and the closure. The placement device is detachably connected to the thread support portion, and a tubular body holding portion that detachably holds the tubular body;
An urging means for urging the yarn support portion in the proximal direction with respect to the tubular body;
A casing having a first part for raising the pin and a second part for lying down;
The casing is provided with a connection release part for releasing the connection between the thread support part and the tubular body holding part, and the thread support part and the tubular body holding part are movably installed,
When the casing is moved in the proximal direction in a state where the anchor of the closure is in contact with the peripheral portion of the hole, the connection between the thread support portion and the tubular body holding portion is released by the connection release portion. The urging means moves the yarn support portion in the proximal direction with respect to the tubular body, the deformation portion is pressed by the distal end portion of the tubular body, and the deformation portion is deformed,
When the casing is further moved in the proximal direction, the yarn support portion moves to the second part of the casing with respect to the casing, the pin falls down, and the proximal end side of the filamentous body is separated from the pin. The in-vivo tissue closure device according to claim 8 or 9, configured to be released.   The arrangement device has an opening that can hold the deformed portion of the closure at the tip, and a long portion that can penetrate the hole;
  A holding member that holds the closure and a part or all of which is movable with respect to the elongated portion;
  A part or all of the holding member moves to the proximal end side with respect to the elongated portion. At this time, the deformed portion of the closing tool is moved from the state where the closing tool is held by the holding member. The in-vivo tissue closing device according to any one of claims 1 to 10, wherein the in-vivo tissue closing device is configured to be held in a distal end portion of a long portion.

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