JP4223417B2 - 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, a device such as a catheter is inserted 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 by incising the thigh. Therefore, it is necessary to stop hemostasis of the puncture hole after the therapeutic treatment is completed, but since the blood pressure at the time of bleeding from the femoral artery (bleeding blood pressure) is high, the medical worker keeps pressing with fingers for a long time ( Such as manual compression) is required.

  In recent years, in order to perform such a hemostasis operation easily and reliably, a suturing device that is inserted through a wound hole and sutures a hole formed in a blood vessel has been developed. For example, a member that can swell in the shape of a hook is provided at the end of the device, and this member is inserted into the blood vessel during suturing, and then swelled in a hook shape. A device has been proposed in which a member is closed, a needle is caught, and an end of the device is pulled out (see, for example, Patent Document 1).

  However, the suturing device having such a configuration has a problem of low reliability in catching the needle. Further, since it is necessary to perform a thread replacement operation after passing the suture thread once, there is a problem that it takes time and labor for the suture.

  On the other hand, as an in vivo tissue closing device, the device described in Patent Document 2 has a hard seal portion and a collagen sponge connected by a thread (for example, see Patent Document 2).

  In the operation method of the device described in Patent Document 2, first, the tip of the main body is inserted through a wound hole in a blood vessel, and the seal portion is developed. Next, the seal portion is brought into contact with the wound hole and the surrounding tissue while slowly pulling out the main body portion. Further, when the main body is pulled while catching the wound hole with the seal portion, the collagen sponge is developed from the tip of the main body into the tissue above the wound hole. Then, the main body part is removed from the body, the thread connected to the seal part and the collagen sponge is pulled, the knot set in advance is advanced, and the seal part and the collagen sponge are pulled together to stop bleeding. Finally, cut the yarn and finish.

  However, in the in-vivo tissue closing device having such a configuration, since only the thread holds the hard seal part in the blood vessel, there is a possibility that the thread breaks during long-term indwelling and the seal part is separated. Conceivable.

Japanese National Patent Publication No. 8-504618 Japanese Patent No. 2562007

  An object of the present invention is to provide a highly safe in-vivo tissue closing device that can easily and surely close a wound formed in an in-vivo tissue membrane and can completely stop bleeding. is there.

The above objects are achieved by the present inventions (1) to ( 12 ) below.
(1) An in-vivo tissue closing device for closing a wound hole penetrating an in-vivo tissue membrane,
An elongate apparatus main body having a tip that can penetrate the wound,
Closing means that is detachably attached to the distal end portion of the apparatus main body, can penetrate the wound hole together with the distal end portion of the apparatus main body, and is placed in a state in which the wound hole is closed after closing the wound hole. When,
Deformation means capable of deforming the closing means,
The closing means includes a seal portion that covers the wound from the inner surface side of the tissue membrane after the wound is closed;
A deformation that can be compressed and deformed from the first form capable of passing through the wound hole to a second form capable of sandwiching the in vivo tissue membrane with the seal portion by operating the deformation means. And
The seal part and the deformation part are integrally formed of the same material ,
The deforming means is detachably attached to the apparatus main body, and has a cylindrical pressing member capable of pressing the deforming portion, and one end side is connected to the closing means through the lumen of the pressing member, and the other end A thread-like member that is pulled out from the apparatus main body to the outside, and by pulling the thread-like member relatively to the proximal direction with respect to the pressing member, the distal end portion of the pressing member presses the deforming portion. The in vivo tissue closing device, wherein the deforming portion is deformed .

  (2) The in-vivo tissue closing device according to (1), wherein the closing means is configured by an aggregate of fibers.

  (3) The in-vivo tissue closing device according to (1) or (2), wherein the closing means is made of a woven fabric or a non-woven fabric.

  (4) The in-vivo tissue closing device according to (1), wherein the closing means is made of a porous material.

  (5) The in-vivo tissue closure device according to any one of (1) to (4), wherein the deformed portion has a hardness lower than that of the seal portion.

(6) The device according to any one of (1) to (5), further including a tightening member that is attached between the deformable portion and the seal portion and holds the deformed portion in the second form. In vivo tissue closure device.

  (7) The tightening member is composed of a thread-like member having a knot movable in one direction, and the deformed portion is in the second form by moving the knot and tightening the thread-like member. The in-vivo tissue closing device according to (6), wherein

( 8 ) In the first embodiment, the deforming portion has a plate shape or a strip shape that is long in the longitudinal direction of the apparatus main body, and in the second embodiment, the deformed portion is alternately folded in opposite directions at a plurality of folds. The in vivo tissue closing device according to any one of (1) to ( 7 ) above.

( 9 ) The seal portion can be deformed from a first form capable of passing through the flawed hole to a second form extending in a direction substantially orthogonal to the longitudinal direction of the apparatus main body. 8 ) The in-vivo tissue closing device according to any one of the above.

( 10 ) The seal portion has an elongated shape, and the longitudinal direction of the seal portion is substantially parallel to the longitudinal direction of the device body, and the longitudinal direction of the seal portion is substantially in the longitudinal direction of the device body. The in-vivo tissue closing device according to any one of (1) to ( 8 ), which can take an orthogonal posture.

( 11 ) The in vivo tissue closing device according to any one of (1) to ( 10 ), wherein at least a part of the closing means is made of a biodegradable material.

( 12 ) The in-vivo tissue closure device according to any one of (1) to ( 11 ), wherein the device main body has a backflush hole through which body fluid can pass from the distal end side to the proximal end side.

  According to the present invention, the safety is high, and hemostasis can be easily and reliably performed on a wound formed in a tissue membrane in a living body. That is, the wound can be easily and reliably closed (closed), and hemostasis can be completely achieved.

  In addition, the sealing part and the deforming part of the closing means are integrally formed, thereby reliably preventing the sealing part and the deforming part from separating after the closing means is placed in the wound hole. Therefore, the hemostatic state can be reliably maintained, and the seal portion does not flow into the tissue in the living body, so that safety is high.

Hereinafter, the in-vivo tissue closing device of the present invention will be described in detail with reference to the drawings.
1 to 10 show a first embodiment of an in-vivo tissue closing device according to the present invention, and FIG. 1 is a perspective view showing a state (first embodiment) before fixing of a closing means, 2 is a perspective view showing a state after fixing of the closing means (second form), FIG. 3 is an explanatory view showing an example of a knot, FIG. 4 is an explanatory view showing another example of the knot, and FIGS. 10 is an explanatory view showing a procedure for fixing the closing means to the wound with the in-vivo tissue closing device.

  For convenience of explanation, in FIGS. 1 and 2, the lower side is the “tip” and the upper side is the “base end”, and in FIGS. 5 to 10, the lower left side is “tip” and the upper right side is “ This will be described as “base end”.

  The in-vivo tissue closing device 1 shown in these drawings is formed in a living tissue membrane such as a living body lumen such as a blood vessel, a living body internal organ, or a living body internal tissue, and percutaneously penetrates a wound (in vivo This is a device for closing (closing) a wound hole penetrating the tissue membrane.

  As shown in FIGS. 1-10, this in-vivo tissue closure apparatus 1 is equipped with the elongate apparatus main body 2 and the front-end | tip part of the apparatus main body 2 so that attachment or detachment is possible, and the wound hole which penetrates the in-vivo tissue film | membrane Closing means 20 for closing 50.

  As shown in FIGS. 5 to 7, the apparatus main body 2 includes a substantially cylindrical sheath 3 having a through hole 6 penetrating in the axial direction at the center, and a long closure that is detachably attached to the sheath 3. 7, and the distal end portion of the sheath 3 and the closure 7 and the closing means 20 penetrate the wound hole 50 during the hemostasis work (work for closing the wound hole), and the lumen of a living body such as a blood vessel. It is inserted into the (biological lumen).

  The sheath 3 has a hub 4 that is thicker than the other parts at the base end portion, and a groove 5 having a semicircular cross section is provided on the outer peripheral surface of the hub 4 in an annular shape over the entire circumference. As the sheath 3, a dedicated one may be used for the in-vivo tissue closing device 1, and a sheath (introducer sheath) to be placed after treatment using a catheter (PCI) or diagnosis (CAG) is used. It may be used. That is, the component of the apparatus main body 2 may or may not include the sheath 3.

  The closure 7 includes a rod-like closure main body 8 mounted in the through hole 6 of the sheath 3 and a deformation means 30 provided on the closure main body 8 and performing an operation of deforming the closing means 20.

  The closure body 8 has a round bar shape that is detachably inserted into the through-hole 6 of the sheath 3, and a hub 9 having a larger diameter than other portions is integrally provided at the base end portion. 9 is provided with an annular groove 10 centered on the center of the hub 9, and the base end portion of the hub 4 of the sheath 3 described above can be fitted into the groove 10.

  The groove 10 of the hub 9 of the closure body 8 is provided with a semicircular projection 11 having a semicircular cross section projecting radially inwardly on the outer peripheral surface, and the groove of the hub 9 of the closure body 8 is provided annularly. When the proximal end portion of the hub 4 of the sheath 3 is fitted into the sheath 10, the projection 11 is fitted into the groove 5 on the sheath 3 side, whereby the closure body 8 is integrally connected to the sheath 3. The

  A through hole 12 penetrating in the axial direction is provided in the central portion of the closure body 8, and this through hole 12 is formed in two stages, a large diameter portion 13 on the distal end side and a small diameter portion 14 on the proximal end side. In the through hole 12 of the closure body 8, a deformed portion 23 of the closing means 20 described later is inserted into the large diameter portion 13, and a pressing member 31 and a thread member 24 of the deforming means 30 described later are inserted into the small diameter portion 14. .

  The inner surface of the large-diameter portion 13 of the through hole 12 of the closure body 8 may be provided with unevenness (not shown) in order to increase the friction coefficient. By this unevenness or the like, the deformed portion 23 of the closing means 20 can be reliably held in the through hole 12 until necessary.

  A portion of the closure body 8 adjacent to the through hole 12 is provided with a backflush hole 15 that penetrates the closure body 8 in the axial direction. The backflush hole 15 has a distal end opened on the end surface on the distal end side of the closure body 8, and a proximal end opened on the peripheral surface of the hub 9 of the closure body 8, and blood in the blood vessel can be passed through the backflush hole 15. It is configured to flow out.

  The closing means 20 includes a seal portion 21 and a deformable portion 23, and the seal portion 21 and the deformable portion 23 are integrally formed of the same material. The first form shown in FIG. From FIG. 2, it can deform | transform into the 2nd form shown in FIG. The closing means 20 is placed in the wound 50 in the second form shown in FIG. 2 after the hemostasis operation (closure operation) of the wound 50, and at that time, the seal portion 21 is in vivo tissue in the vicinity of the wound 50. The deformed portion 23 contacts (adheres) to the outer surface side of the in vivo tissue film (blood vessel wall) in the vicinity of the wound 50.

  In the first form shown in FIG. 1, the seal portion 21 has a shape such that a groove 22 having a predetermined width and depth is provided from the upper surface to the lower side in the center portion of the substantially cylindrical shape. Yes. One end of the deforming portion 23 is integrally connected to the bottom of the groove 22. The seal portion 21 can pass through the flaw hole 50 in the first embodiment.

  In the second form shown in FIG. 2, the seal portion 21 is formed in a shape in which both sides rotate and open around the base of the deformable portion 23 and expand in a direction substantially perpendicular to the longitudinal direction of the apparatus body 2. Become. The deformation of the seal portion 21 from the first form to the second form can occur spontaneously by the elastic force.

  In the first embodiment shown in FIG. 1, the deformable portion 23 has a plate shape or a belt shape that is long in the longitudinal direction (axial direction) of the apparatus main body 2, and one end portion thereof is integrally connected to the bottom portion of the groove 22 of the seal portion 21. In the first embodiment, the wound hole 50 can be passed.

  In the 2nd form shown in FIG. 2, the deformation | transformation part 23 is alternately folded by the crease | fold of several places along a longitudinal direction, and becomes a compressed shape. In this way, the deformed portion 23 is compressed in the longitudinal direction and deformed into a second form in which the deformed portion 23 expands in a direction perpendicular to the longitudinal direction, so that the living body in the vicinity of the wound 50 is formed between the seal portion 21 and the living body. Tissue membrane (blood vessel wall) can be sandwiched.

  Here, the deformation of the deformable portion 23 is compressed by applying a pressing force in the longitudinal direction of the deformable portion 23 such that the density of at least a part of the deformable portion 23 contracts, and the partial portion extends in a direction perpendicular to the longitudinal direction. The phenomenon that spreads is used.

  The material of the closing means 20 is not particularly limited, but is preferably mainly composed of a fiber assembly.

  As a method of manufacturing the closing means 20 mainly with an aggregate of fibers, for example, a plurality of cloth-like bodies (woven fabric or non-woven fabric) are overlapped and stitched together with a thread or attached with a binder (adhesive) to be integrated. And a method of directly solidifying an aggregate of yarns (fibers) with a binder.

  The seal portion 21 can be made relatively by means such as sewing together at more places when the overlapped cloth-like bodies are sewn with a thread, or increasing the amount of the binder or performing high compression when using a binder. It is preferable to form it hard (to high hardness). Thereby, the wound hole 50 can be closed more reliably.

  On the other hand, the deforming portion 23 is a means for reducing the number of stitched portions when sewing the overlapped cloth-like bodies with a thread, or reducing the amount of the binder or reducing the compression when using a binder. Therefore, it is preferable to form softer (lower hardness) than the seal portion 21. Thereby, the deformation | transformation part 23 can be made easier to deform | transform.

  Further, the closing means 20 can be constituted by a sponge-like porous body made of a synthetic resin material. In this case, the deformable portion 23 can be formed flexibly and the seal portion 21 can be formed relatively rigid by appropriately adjusting the porosity of the porous body, the diameter of the pores, and the like.

  Such a closing means 20 is preferably formed at least partially (for example, a constituent fiber) with a bioabsorbable material (a material having biodegradability). By forming with such a material, it is absorbed by the living body after a predetermined time has elapsed, so that the influence on the human body can be reduced. Examples of the bioabsorbable material include simple substances such as polylactic acid, polyglycolic acid, and polydioxanone, or composites thereof.

  As shown in FIG. 1, a single thread-like member 24 is attached to the deforming portion 23 as a fastening member that holds the deformed portion 23 in a deformed state in a second form. The thread-like member 24 forms a knot 25 having a shape as shown in FIG. 3 or 4 on the proximal end side of the deformable portion 23.

  The knot 25 has a knot that can be moved only in the tip direction. By moving the knot 25 in the tip direction and tightening the thread-like member 24, the deformed portion 23 is deformed into the second form shown in FIG. The second form can be maintained.

  The thread-like member 24 is also preferably made of a bioabsorbable material like the closing means 20. The thread-like member 24 is also used as the thread-like member 24 of the deformation means 30 described below.

  The deforming means 30 is for fixing the closing means 20 to the wound hole 50 in the in vivo tissue membrane by deforming the deforming portion 23 of the closing means 20 into the second form. As shown, it is composed of a thread-like member 24 attached to the closing means 20 and a tube-like (tubular) pressing member 31 that can be inserted through the thread-like member 24 and press the deformable portion 23.

  The pressing member 31 of the deformation means 30 is mounted in the small diameter portion 14 of the through hole 12 of the closure body 8, and in the initial state, the distal end portion projects into the large diameter portion 13 of the through hole 12, and the proximal end portion is the through hole 12. A predetermined length protrudes from the small diameter portion 14 to the outside.

  Next, a procedure of hemostasis work performed using the in-vivo tissue closing apparatus 1 according to the present embodiment configured as described above will be described.

  First, a thread-like member 24 is attached between the deforming portion 23 of the closing means 20 and the seal portion 21, and a knot 25 as shown in FIG. 3 or FIG. 4 is attached to a portion adjacent to the deforming portion 23 of the thread-like member 24. In this state, the thread-like member 24 is inserted into the pressing member 31.

  Next, the pressing member 31 is inserted into the through hole 12 of the closure body 8 from the distal end side opening, and the proximal end portion of the pressing member 31 is protruded to the outside from the proximal end opening portion of the through hole 12 of the closure body 8. Then, the deforming portion 23 of the closing means 20 is inserted into the large diameter portion 13 of the through hole 12, and the seal portion 21 is brought into close contact with the distal end surface of the closure body 8.

  Next, as shown in FIG. 5, the first form in a state in which the seal portion 21 of the closing means 20 is closed in the through hole 6 of the sheath 3 already inserted into the wound hole 50 of the tissue membrane in the living body. Insert closure 7 as

  Then, as shown in FIG. 6, the closure 7 is further inserted in the distal direction with respect to the sheath 3, and the hub 4 of the sheath 3 is fitted into the groove 10 of the hub 9 of the closure body 8. 11 is engaged with the groove 5 of the sheath 3. As a result, the closure body 8 is connected to the sheath 3, and the seal portion 21 of the closing means 20 comes out of the distal end opening of the sheath 3 and spontaneously opens in the blood vessel due to elasticity, and is transformed into the second form. Further, when the seal portion 21 is opened, blood flows into the backflush hole 15 of the closure body 8 from the opening on the front end side, and flows out of the closure body 8 through the backflush hole 15.

  Next, as shown in FIG. 7, after confirming blood backflushing, the closure 7 and the sheath 3 are slowly pulled in the proximal direction, and the seal portion 21 of the closing means 20 is moved to the inner surface of the tissue membrane (blood vessel wall) in the living body. Abut. At this time, the deforming portion 23 is held on the inner surface of the large-diameter portion 13 by friction. As a result, the blood in the blood vessel is stopped from flowing into the backflush hole 15 of the closure body 8, the blood outflow is stopped, and the seal portion 21 of the closing means 20 is placed on the inner surface side of the wound hole 50 in the blood vessel. It is confirmed that they are pressed.

  Next, as shown in FIG. 8, when the closure 7 and the sheath 3 are further pulled in the proximal direction, the deformed portion 23 is removed from the large-diameter portion 13, and the closure 7 and the sheath 3 are removed from the wound hole 50. Can do. As a result, the pressing member 31 and the thread-like member 24 of the deformation means 30 protrude from the puncture site of the skin.

  From this state, as shown in FIG. 9, while pulling the thread-like member 24 in the proximal direction, the pressing member 31 is pressed in the distal direction, and the knot 25 is pushed at the distal end of the pressing member 31, The thread-like member 24 is tightened between the deformable portion 23 and the deformable portion 23. As a result, the deformed portion 23 is compressed so as to be folded and deformed into the second form, and the knot 25 does not return in the proximal direction as described above. State is maintained. In this manner, the in-vivo tissue membrane in the vicinity of the wound 50 is sandwiched between the seal portion 21 and the deformed portion 23, and the wound 50 is closed.

  Next, as shown in FIG. 10, the pressing member 31 is removed from the puncture site, and the portion of the thread-like member 24 protruding outside the body is cut. In this way, the sealing portion 21 and the deforming portion 23 of the closing means 20 are fixed in the blood vessel wound hole 50, and the blood vessel wound hole 50 can be closed to stop bleeding.

  In the present invention, since the sealing portion 21 and the deforming portion 23 of the closing means 20 are integrally formed of the same material in this way, after the closing means 20 is placed in the flaw hole 50 and closed, It is possible to reliably prevent the seal portion 21 and the deformable portion 23 from separating, and the hemostatic state can be reliably maintained. Further, since the seal portion 21 is not separated from the deformable portion 23 and flows into the blood vessel, the safety is high.

Hereinafter, another configuration example of the closing means 20 will be described with reference to FIGS.
The closure means 20 shown in FIGS. 11 to 14 has a seal portion 21 formed in an elongated elliptical plate shape having a curved lower surface and a flat upper surface, and a narrow neck portion necked at the center of the upper surface of the seal portion 21. 26, a rectangular plate-shaped deforming portion 23 is integrally provided, and other configurations are the same as those shown in FIGS.

  A portion of the deformable portion 23 adjacent to the neck portion 26 is formed on an inclined surface whose thickness is gradually reduced toward the neck portion 26. The closing means 20 of this modification is also compressed so that the deformed portion 23 is folded by propelling the knot 25 of the thread-like member 24 in the same manner as shown in FIGS. It deform | transforms into a form (refer FIG. 14), a biological tissue film is pinched | interposed between the seal | sticker part 21 and the deformation | transformation part 23, and the wound 50 is closed.

  In a state where the closing means 20 is fixed to the flaw hole 50, the thin neck portion 26 passes through the flaw hole 50. Thereby, the flaw hole 50 becomes easier to close, and hemostasis can be performed more quickly and reliably.

  Further, the seal portion 21 is not foldable in two, and can be rotated around the neck portion 26 so as to be parallel to the deformed portion 23 as shown by a two-dot chain line in FIG. It has become. When the closing means 20 is inserted into the sheath 3, the longitudinal direction of the seal portion 21 is substantially parallel to the longitudinal direction of the apparatus body 2, and the posture shown by the two-dot chain line in FIG. When closing, the longitudinal direction of the seal portion 21 is set to a posture indicated by a solid line in FIG. 13 which is substantially orthogonal to the longitudinal direction of the apparatus main body 2.

  The closing means 20 shown in FIG. 15 is the same as the closing means 20 shown in FIGS. 11 to 14 except that the neck portion 26 is not provided, and the knot 25 of the thread-like member 24 is the same as that shown in FIGS. 1 and 2. By propelling, the deformation part 23 is deformed so as to be folded, the seal part 21 is held in pressure contact with the inner surface side of the in vivo tissue membrane, and the wound 50 is closed. In the closing means 20, the absence of the neck portion 26 can surely prevent the deformed portion 23 and the seal portion 21 from being twisted. Moreover, since the shape is simple, it can be manufactured easily.

  The closing means 20 shown in FIG. 16 has a round bar shape on the upper part of the sealing part 21 having the same configuration as the closing means 20 shown in FIGS. 11 to 15 and has a semicircular cross section at a part adjacent to the sealing part 21. The deformed portion 23 in which the notch 231 is formed is integrally provided, and other configurations are the same as those shown in FIGS. 1 and 2. And the closing means 20 of this modification is also deformed so that the deformed portion 23 is folded by propelling the knot 25 of the thread-like member 24 as shown in FIG. 1 and FIG. The wound 50 is closed while being held in pressure contact with the inner surface of the tissue membrane in the living body. When the closing means 20 is inserted into the sheath 3, the seal portion 21 is rotated 90 ° in the direction of the arrow in the figure, and the longitudinal direction of the seal portion 21 is substantially parallel to the longitudinal direction of the apparatus body 2. In this case, since the upper half of the seal portion 21 is housed in the notch 231, it can be easily inserted into the sheath 3.

  The closing means 20 shown in FIGS. 17 and 18 has an elliptical annular shape that is long in the natural state (first form) on the top of the seal portion 21 having the same configuration as the closing means 20 shown in FIGS. The portion 23 is integrally provided (see FIG. 17), and other configurations are the same as those shown in FIGS. The closing means 20 is also deformed so that the deformed portion 23 is crushed from above and below by propelling the knot 25 of the thread-like member 24 in the same manner as shown in FIGS. It becomes the 2nd form extended in the direction substantially orthogonal to the direction (refer FIG. 18). In the state shown in FIG. 18, the in vivo tissue membrane is held between the seal portion 21 and the deformable portion 23, and the wound hole 50 is closed.

  The closing means 20 shown in FIG. 19 and FIG. 20 is a natural state (first form) shown in FIG. In the first embodiment, the upper and lower elliptical annular deformable portions 23 are inserted, and the thread-like member 24 is inserted through the deformable portion 23 and the seal portion 21 repeatedly. And it is the same as that shown in FIG. In the closing means 20, the knot 25 of the thread-like member 24 is propelled, whereby the deforming portion 23 is deformed so as to be crushed from above and below, and spreads in a direction substantially perpendicular to the longitudinal direction of the apparatus body 2. In addition to the form, the seal portion 21 is similarly compressed and deformed so as to be crushed from above and below, and becomes a second form spreading in a direction substantially perpendicular to the longitudinal direction of the apparatus body 2 (FIG. 20). In the state of FIG. 20, the tissue tissue in the vicinity of the wound 50 is held between the deformable portion 23 and the seal portion 21, and the wound 50 is closed. Such a closing means 20 can be formed particularly easily by using a porous body as a constituent material.

  21 to 29 show a second embodiment of the in-vivo tissue closing device according to the present invention. FIG. 21 is a perspective view showing the entire in-vivo tissue closing device, and FIG. FIG. 23 is a schematic view showing a state before fixing (first form), FIG. 23 is a perspective view showing a state after fixing of the closing means (second form), and FIGS. It is explanatory drawing which shows the procedure which fixes to a wound hole.

  For convenience of explanation, in FIG. 21 and FIGS. 24 to 29, the lower left side in the figure is described as “tip” and the upper right side is described as “base end”.

  As shown in FIG. 22, the deforming part 23 of the closing means 20 in the in-vivo tissue closing apparatus 1 shown in this embodiment has a high water absorption property inside a bag-like member 27 having an internal space constituted by a cloth-like body. The swelling material 28 made of a swelling material is housed. Although it does not specifically limit as a highly water-absorbing swelling material which comprises the swelling material 28, For example, polysaccharides, such as alginic acid, CMC (carboxymethylcellulose), chitin, chitosan, polyethyleneglycol, etc. are mentioned.

  Such a deformation | transformation part 23 (bag-like member 27) is integrally formed with the seal | sticker part 21 with the same material similarly to embodiment mentioned above. The deformable portion 23 can swell as shown in FIG. 23 when the internal swelling material 28 absorbs the body fluid in the living body and expands.

  Moreover, as shown in FIG. 24, the in-vivo tissue closing device 1 of this embodiment forms the through-hole 12 of the closure main body 8 in the shape where the front end side becomes thin, and the deformation | transformation of the closure means 20 in this thinly formed part. By inserting the portion 23, the closing means 20 is held at the tip of the closure body 8, and the through-hole 12 is also used as a back flush hole. In addition, a slit 81 is formed along the longitudinal direction in the front end portion of the closure body 8. Thereby, the diameter of the through-hole 12 can be expanded in the part of the front end side of the closure main body 8 when the slit 81 opens. Further, a protrusion 111 positioned on the distal end side and a protrusion 112 positioned on the proximal end side are formed on the inner surface of the groove 10 of the hub 9, and the fixing position with respect to the sheath 3 can be selected in two stages. Yes. Since other configurations are the same as those shown in the first embodiment, the same parts as those shown in the first embodiment are denoted by the same reference numerals and detailed description thereof is omitted. Shall.

  In order to perform hemostasis using the in-vivo tissue closing apparatus 1 according to the present embodiment configured as described above, first, as shown in FIGS. 21 and 24, the deformed portion 23 or seal of the closing means 20 is used. A holding thread-like member 29 is attached to the portion 21, and the thread-like member 29 is inserted inside the pressing member 31. Then, the pressing member 31 is inserted into the through hole 12 of the closure body 8 from the opening on the front end side, the thread-like member 29 is protruded to the outside from the opening on the base end side of the through hole 12, and the deformed portion 23 of the closing means 20 is It inserts in the through-hole 12 from the front end side opening.

  Next, as shown in FIG. 24, the closure 7 is inserted into the through-hole 6 of the sheath 3 already inserted into the wound hole 50 of the tissue membrane in the living body with the closing means 20 held at the tip. The distal end portion of the closure 7 and the closing means 20 are inserted into the blood vessel through the wound hole 50, the hub 4 of the sheath 3 is fitted into the groove 10 of the hub 9 of the closure body 8, and the first stage of the closure body 8 is The protrusion 111 is engaged with the groove 5 of the sheath 3. By connecting the closure main body 8 to the sheath 3 in this manner, blood in the blood vessel flows into the through hole 12 of the closure main body 8 from the opening on the distal end side, and flows out of the closure main body 8 through the through hole 12. . In addition, on the inner peripheral surface of the distal end portion of the through hole 12, a liquid passage groove 121 is formed along the longitudinal direction so as to allow the backflush blood to pass therethrough. In this state, the sheath 3 prevents the slit 81 at the tip of the closure body 8 from opening, so that the deformed portion 23 is securely held in the through hole 12.

  Next, as shown in FIG. 25, after confirming blood backflushing, the closure 7 and the sheath 3 are slowly pulled in the proximal direction, and the seal portion 21 of the closing means 20 is brought into contact with the inner surface of the in vivo tissue. As a result, the blood in the blood vessel is stopped from flowing into the through hole 12 of the closure body 8, the blood outflow is stopped, and the seal portion 21 of the closing means 20 is pressed against the inner surface side of the blood vessel wound hole 50. Confirmed.

  Next, as shown in FIG. 26, the sheath 3 is pulled in the proximal direction with respect to the closure 7, and the second-stage protrusion 112 of the closure body 8 is engaged with the groove 5 of the sheath 3. Thereby, when the whole slit 81 comes out from the front-end | tip of the sheath 3, the slit 81 opens, the front-end | tip part of the through-hole 12 expands, and the holding state with respect to the deformation | transformation part 23 of the closure means 20 is cancelled | released.

  When the closure 7 and the sheath 3 are removed from the puncture site from this state, as shown in FIG. 27, the closing means 20 remains in the flaw hole 50 and the pressing member 31 and the thread-like member 29 of the deformation means 30 from the flaw hole 50. Will protrude.

  Furthermore, as shown in FIG. 28, while pulling the thread-like member 29, the pressing member 31 is pressed in the distal direction, the deforming portion 23 is pressed by the leading end portion of the pressing member 31, and the deforming portion 23 is folded so as to be folded.

  Then, the deformed portion 23 is held in a deformed state for a predetermined time, and as shown in FIG. 29, the swelling material 28 of the deformed portion 23 absorbs bodily fluids such as blood inside the blood vessel or exudate outside the blood vessel to swell. . As a result, the closing means 20 is fixed to the flaw hole 50. Thereafter, the pressing member 31 and the thread-like member 29 are removed from the puncture site. In this way, the sealing portion 21 and the deforming portion 23 of the closing means 20 are fixed in the blood vessel wound hole 50, and the blood vessel wound hole 50 can be closed to stop bleeding.

  As described above, the in-vivo tissue closing device of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the in-vivo tissue closing device exhibits the same function. It can be replaced with any configuration obtained. Moreover, arbitrary components may be added.

It is the perspective view which showed the state (1st form) before fixation of the closure means used for the in-vivo tissue closure apparatus of 1st Embodiment by this invention. It is the perspective view which showed the state (2nd form) after fixing of the closing means of FIG. It is explanatory drawing which showed an example of the knot of the closing means shown in FIG. 1 and FIG. It is explanatory drawing which showed the other example of the knot of the closing means of FIG. 1 and FIG. It is explanatory drawing which showed the procedure which fixes a closing means to a wound hole by the in-vivo tissue closure apparatus of 1st Embodiment by this invention, Comprising: It is explanatory drawing which showed the state which mounted | wore the sheath and the closing means. is there. It is explanatory drawing which showed the state which inserted the closure means in the biological body tissue from the wound hole, and the backflushing started. It is explanatory drawing which showed the state which moved in the direction which pulls out a sheath and a closure, the sealing part of the closing means was press-contacted to the inner surface side of the flaw hole, and the back flush stopped. It is explanatory drawing which showed the state which extracted the sheath and the closure main body. It is explanatory drawing which showed the state which deform | transformed the deformation | transformation part of the closing means by cooperation with a press member and a thread | yarn member. It is explanatory drawing which showed the state which extracted the press member from the wound and cut | disconnected the thread-like member. It is the perspective view (1st form) which showed the other example of the closure means. It is a front view of FIG. It is a side view of FIG. It is explanatory drawing which showed the state (2nd form) after a deformation | transformation of the deformation | transformation part of the closure means of FIG. It is the perspective view which showed the other example of the closure means. It is the perspective view which showed the other example of the closure means. It is the perspective view which showed the other example of the closure means, Comprising: It is explanatory drawing which showed the state (1st form) before a deformation | transformation part. It is explanatory drawing which showed the state (2nd form) after a deformation | transformation of the deformation | transformation part of the closure means of FIG. It is the perspective view which showed the other example of the closure means, Comprising: It is explanatory drawing which showed the state (1st form) before a deformation | transformation part. It is explanatory drawing which showed the state (2nd form) after a deformation | transformation of the deformation | transformation part of the closing means of FIG. It is the perspective view which showed the closure and closing means of the in-vivo tissue closing device of 2nd Embodiment by this invention. It is explanatory drawing which showed the state (1st form) before fixation of the closure means used for the portable tissue closure apparatus of 2nd Embodiment. It is explanatory drawing which showed the state (2nd form) after fixing of the closing means of FIG. It is explanatory drawing which showed the procedure which fixes a closure means to a wound hole by the in-vivo tissue closure apparatus of 2nd Embodiment by this invention, Comprising: The state which attached | subjected the closure and the closure means to the sheath, and the backflush started It is explanatory drawing which showed. It is explanatory drawing which showed the state which moved in the direction which pulls out a sheath and a closure, the sealing part of the closing means was press-contacted to the inner surface side of the flaw hole, and the back flush stopped. It is explanatory drawing which showed the state in the middle of extracting a sheath and a closure main body from a wound hole. It is explanatory drawing which showed the state which extracted the sheath and the closure main body from the wound hole. It is explanatory drawing which showed the state which deform | transformed the deformation | transformation part of the closing means by cooperation with a press member and a thread | yarn member. It is explanatory drawing which showed the state which swollen the deformation | transformation part of the closing means, extracted from the press member and the thread-like member wound hole, and fixed the closing means to the wound hole.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Biological tissue closure apparatus 2 Apparatus main body 3 Sheath 4 Hub 5 Groove 6 Through-hole 7 Closure 8 Closure main body 81 Slit 9 Hub 10 Groove 11 Projection 111 Projection 112 Projection 12 Through-hole 121 Liquid passage groove 13 Large diameter part 14 Small diameter part 15 Back flush hole 20 Closing means 21 Seal part 23 Deformation part 231 Notch 24 Threaded member 25 Knot 26 Neck part 27 Bag-like member 28 Swelling material 29 Threaded member 30 Deformation means 31 Pressing member 50 Wound hole

Claims (12)

An in-vivo tissue closing device for closing a wound hole penetrating an in-vivo tissue membrane,
An elongate apparatus main body having a tip that can penetrate the wound,
Closing means that is detachably attached to the distal end portion of the apparatus main body, can penetrate the wound hole together with the distal end portion of the apparatus main body, and is placed in a state in which the wound hole is closed after closing the wound hole. When,
Deformation means capable of deforming the closing means,
The closing means includes a seal portion that covers the wound from the inner surface side of the tissue membrane after the wound is closed;
A deformation that can be compressed and deformed from the first form capable of passing through the wound hole to a second form capable of sandwiching the in vivo tissue membrane with the seal portion by operating the deformation means. And
The seal part and the deformation part are integrally formed of the same material ,
The deforming means is detachably attached to the apparatus main body, and has a cylindrical pressing member capable of pressing the deforming portion, and one end side is connected to the closing means through the lumen of the pressing member, and the other end A thread-like member that is pulled out from the apparatus main body to the outside, and by pulling the thread-like member relatively to the proximal direction with respect to the pressing member, the distal end portion of the pressing member presses the deforming portion. The in vivo tissue closing device, wherein the deforming portion is deformed .   The in-vivo tissue closing device according to claim 1, wherein the closing means is composed of an aggregate of fibers.   The in-vivo tissue closing device according to claim 1 or 2, wherein the closing means is made of a woven fabric or a non-woven fabric.   The in-vivo tissue closing device according to claim 1, wherein the closing means is made of a porous material.   The in-vivo tissue closure device according to any one of claims 1 to 4, wherein a hardness of the deformable portion is lower than a hardness of the seal portion. The in-vivo tissue closure device according to any one of claims 1 to 5 , further comprising a fastening member attached between the deformable portion and the seal portion and holding the deformed portion in a state of being in the second form. .   The tightening member is composed of a thread-like member having a knot that is movable in one direction, and the deformed portion is held in the second form by moving the knot and tightening the thread-like member. The in-vivo tissue closure device according to claim 6. In the first embodiment, the deforming portion has a plate shape or a strip shape that is long in the longitudinal direction of the apparatus main body, and in the second embodiment, the deforming portion is alternately folded in opposite directions at a plurality of folds. Item 8. The in vivo tissue closing device according to any one of Items 1 to 7 . The seal portion from the first embodiment that can pass through the wound hole, to either the second of claims 1 is deformable to form 8 spread in a direction substantially perpendicular to the longitudinal direction of the device body The in-vivo tissue closure device described. The seal portion has an elongated shape, and a posture in which the longitudinal direction of the seal portion is substantially parallel to the longitudinal direction of the device body, and a posture in which the longitudinal direction of the seal portion is substantially orthogonal to the longitudinal direction of the device body. The in-vivo tissue closure device according to any one of claims 1 to 8 . The in-vivo tissue closing device according to any one of claims 1 to 10 , wherein at least a part of the closing means is formed of a biodegradable material. The in-vivo tissue closure device according to any one of claims 1 to 11 , wherein the device main body has a backflush hole through which body fluid can pass from the distal end side to the proximal end side.

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