JP2005261509A - Biological tissue closing device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biological tissue closing device with which an injury hole formed in a biological tissue membrane can be easily and securely closed. <P>SOLUTION: The biological tissue closing device 1 for closing the injury hole passing through the biological tissue membrane is equipped with a device main body 2 whose distal end part can be inserted to the biological tissue through the injury hole and a closing means 46 which is detachably mounted on the distal end part of the device main body 2, can be inserted to the biological tissue together with the distal end part of the device main body 2 and closes the injury hole by being brought into press contact with the inner and outer surfaces of the biological tissue. The closing means 46 is inserted into the biological tissue by the operation of the device main body 2 and is fixed in the state of being brought into press contact with the inner and outer surfaces of the biological tissue, and the injury hole is closed. <P>COPYRIGHT: (C)2005,JPO&NCIPI

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 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 already 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, the collagen sponge is propelled toward the wound from the main body having the same diameter as the wound, so that the collagen sponge is inserted into the blood vessel. There's a problem.
In addition, the collagen sponge may expand within the tip of the main body and may not come out of the main body.

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 (10) below.
(1) An in-vivo tissue closing device for closing a wound hole penetrating an in-vivo tissue membrane,
An inner seal portion that covers the wound hole from the inside of the biological tissue membrane; an outer seal portion that covers the wound hole from the outer side of the biological tissue membrane; and the inner seal portion and the outer portion that are inserted through the wound hole. A closing means having a connecting portion for connecting the seal portion;
An elongate apparatus main body having a holding means for detachably holding the outer seal part of the closing means at the tip part, the tip part of which can be inserted into a living tissue through the wound hole;
A plurality of long needles installed to be able to advance and retreat with respect to the device body so as to extend in a distal direction beyond the tip of the device body and in a position retracted in the proximal direction, and having a needle tip at the tip Members,
An anchor member that is detachably attached to the distal end portion of each needle member, is capable of piercing the tissue tissue and the inner seal portion with the needle tip, and has a thread insertion hole;
A thread-like member inserted into a through-hole formed in the outer seal portion and a thread insertion hole of the anchor member;
An in-vivo tissue closing device comprising: a fastening means for fastening the thread-like member.

  (2) The anchor member is advanced in the distal direction in a state where the closing means is supported by the apparatus main body so that the inner seal portion covers the wound from the inner surface side of the in vivo tissue membrane. A member penetrates the in vivo tissue membrane and the inner seal portion together with the needle tip, and then retracts the needle member, whereby the anchor member remains in the inner seal portion, and then the outer seal portion of the holding means The in-vivo tissue membrane in the vicinity of the wound hole is sandwiched between the outer seal portion and the inner seal portion by releasing the holding state against the wound, and then tightening the thread-like member by the tightening means. The in-vivo tissue closing device according to (1), wherein the device is configured to be closed.

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

  (4) The in-vivo tissue closing device according to any one of (1) to (3), wherein at least a part of the closing means is formed of a woven fabric or a non-woven fabric.

  (5) Each of the inner seal portion and the outer seal portion has a plate shape, and substantially central portions of both are connected via the connecting portion, and the outer seal portion is connected to the connecting portion. The in-vivo tissue closing device according to any one of (1) to (4), wherein the in-vivo tissue closing device is capable of being deformed into a posture folded around a crease and an open posture.

(6) On one end side of the thread-like member, a ring that passes through the through hole of the outer seal portion and the thread insertion hole of the anchor member, and a knot that is movable in one direction are formed,
The in vivo tissue closure device according to any one of (1) to (5), wherein the tightening means tightens the thread-like member by moving the knot so that the ring is small.

  (7) The tightening means includes a plurality of tubes that are inserted through the other end side of the thread-like member, and a gripping portion that is fixed to the thread-like member that protrudes from a proximal end opening of the tube, The in vivo tissue closing device according to (6), wherein the thread-like member is tightened by relatively pulling the grip portion in the proximal direction.

  (8) The holding means includes a holding thread-like member that is inserted into the apparatus main body and has a distal end connected to the outer seal part of the closing means, and the outer seal part is caused by tension of the holding thread-like member. The in-vivo tissue closure device according to any one of (1) to (7), wherein

  (9) The raw material according to any one of (1) to (8), wherein a portion on the distal end side of the needle member can protrude / immerse from an opening formed near the distal end in the apparatus main body. Body tissue closure device.

  (10) The in-vivo tissue closing device according to any one of (1) to (9), wherein the closing means is made of a bioabsorbable material.

  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 particular, since the wound hole is sandwiched between the inner and outer surfaces by the inner seal portion and the outer seal portion, the wound hole can be reliably closed and blood can be reliably stopped. Further, the inner seal portion and the outer seal portion are fixed not only by the wound hole penetrating the tissue tissue in the living body but also by at least two places around the inner periphery, so that the inner seal portion and the outer seal portion do not come off due to changes over time. Highly reliable hemostasis is possible. The in vivo tissue closing device of the present invention uses a needle and a thread, but unlike a conventional suturing device, a plurality of threads are passed through the in vivo tissue membrane, and the holes passed therethrough are not tightened with the thread. There is no risk that the hole through which the thread is passed will be damaged by the thread. In addition, the work of closing a wound is extremely simple and can be performed quickly and reliably.

Hereinafter, the in-vivo tissue closing device of the present invention will be described in detail with reference to the drawings.
1 to 12 show an embodiment of an in-vivo tissue closing device according to the present invention. FIGS. 1 and 2 are a cross-sectional view and a perspective view showing the entire in-vivo tissue closing device, respectively. 3 is a perspective view of the closing means and the knot pusher (clamping means), FIG. 4 is an explanatory view showing an example of a knot, FIG. 5 is an explanatory view showing another example of the knot, and FIGS. 6 to 12 are shown in FIG. It is explanatory drawing for demonstrating the effect | action of the in-vivo tissue closure apparatus.

  1, 2, and 6 to 12, the lower left side in the figure is “tip”, the upper right side (hand side) is “base end”, and FIG. 3 is the lower side in the figure. In the description, the side is the “tip”, the upper side is the “base end”, and in FIGS. 4 and 5, the upper side is the “tip” and the lower side is the “base end”.

  The in-vivo tissue closing device 1 shown in these drawings is formed in, for example, a living body lumen such as a blood vessel, a living body internal organ, a living body tissue such as a living body tissue, and a perforated wound 55 (living). It is a device that closes (closes) a wound hole that penetrates a tissue tissue in a body.

  As shown in FIG. 1, this in-vivo tissue closing device 1 is detachably attached to an elongate device main body 2 and a distal end portion of the device main body 2 and closes a wound hole 55 penetrating the in-vivo tissue membrane. Closing means 46.

  The apparatus main body 2 includes a substantially cylindrical sheath 3 having a through-hole 7 penetrating in the axial direction at the center, and a long closure 8 that is detachably attached to the sheath 3, and is used for hemostasis ( In the operation of closing the wound hole), the distal end portion of the sheath 3 and the closure 8 and the closing means 46 penetrate the wound hole 55 and are inserted into a body lumen (biological lumen) such as a blood vessel. .

  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 8 includes a rod-like closure main body 9 that is mounted in the through hole 7 of the sheath 3, and holding means 27 that is mounted on the closure main body 9. The distal end portion of the closure body 9 is formed on a tapered surface 10 having a predetermined angle so that the closure body 9 can be easily inserted into the wound hole 55 of the tissue tissue in vivo.

  A central portion of the closure body 9 is provided with a first through hole 11 that passes through the closure body 9 in the axial direction, and a knot pusher (clamping means) 31 to be described later is housed in the first through hole 11. Yes.

  On both sides of the first through hole 11 of the closure main body 9, two through holes, a second through hole 12 and a third through hole 14 that penetrate the closure main body 9 in the substantially axial direction, are symmetrical about the first through hole 11. Is provided. A long needle member 41 having a sharp needle tip at the tip is inserted into the second through hole 12 and the third through hole 14 so as to be freely slidable (advanced and retracted).

  As shown in FIGS. 1 and 2, the tips of the second through-hole 12 and the third through-hole 14 open in an elliptical shape on the outer surface side of the tip of the closure body 9, and the second through-hole 12 and the third through-hole 12. Needle members 41, 41 are configured to be able to protrude and retract from the openings 13, 15 on the distal end side of the through hole 14.

  A hub 16 that is thicker than the other parts is integrally provided at the base end portion of the closure body 9, and an annular groove 17 is formed on the end surface of the distal end side of the hub 16 around the center of the closure body 9. The base end portion of the hub 4 of the sheath 3 described above can be fitted into the groove 17.

  The groove 17 of the hub 16 of the closure body 9 is provided with a semicircular cross-sectional protrusion 18 projecting radially inwardly on the outer peripheral surface, and the groove 16 of the hub 16 of the closure body 9 is provided annularly. When the proximal end portion of the hub 4 of the sheath 3 is fitted into the sheath 17, the projection 18 on the closure body 9 side is fitted into the groove 5 on the sheath 3 side, so that the closure body 9 is moved to the sheath 3. Are integrally connected to each other.

  A slide hole 19 having a circular cross section is provided at a predetermined depth at the center of the end surface of the base end side of the hub 16 of the closure body 9. The base end sides of the through hole 12 and the third through hole 14 are open.

  The hub 16 of the closure body 9 is provided with a suture outlet 20 that penetrates the inside and outside of the slide hole 19 in the radial direction, and a holding suture (holding thread-like member) 28 of the holding means 27 described later is provided from the suture outlet 20. Pulled out. A lock cap 29 of a holding means 27 is detachably attached to the suture puller outlet 20, and a holding suture 28 is held by the closure body 9 by the lock cap 29 and is attached to the tip of the holding suturer 28, which will be described later. The closing means 46 is prevented from falling off the closure body 9.

  A back flush outlet 22 that penetrates the inside and outside of the slide hole 19 in the radial direction is provided at a position of the closure body 9 opposite to the suture outlet 20 of the hub 16, and the closure body 9 is provided via the back flush outlet 22. Body fluid (blood) that has flowed into the first through hole 11 from the opening on the front end side flows out to the outside.

  A needle pusher 23 as an operation member for operating the needle member 41 is slidably mounted in the slide hole 19 of the hub 16 of the closure body 9. The needle pusher 23 includes a columnar pusher body 24 slidably mounted in the slide hole 19 and a flange 25 having a larger diameter than the pusher body 24 integrally provided on the proximal end side of the pusher body 24. ing.

  A compression spring 26 is wound around the pusher body 24 of the needle pusher 23, one end of the compression spring 26 abuts on the end surface of the hub 16 of the closure body 9, and the other end is a surface on the flange 25 side. Abut. The compression spring 26 constantly urges the needle pusher 23 in a direction away from the closure main body 9, and presses the needle pusher 23 against the urging force of the compression spring 26 toward the distal end of the closure main body 9. Needle members 41, 41 are pressed in the same direction.

  As shown in FIGS. 2 and 3, the closing means 46 includes a substantially elliptical plate-like inner seal portion 47, a plate-like outer seal portion 48 connected to the upper portion of the inner seal portion 47, and an inner seal portion 47. And an outer seal portion 48.

  As shown in FIG. 12, after the closing operation (hemostatic operation) of the wound hole 55 is completed, the inner seal portion 47 covers the wound hole 55 from the inside of the blood vessel wall (in vivo tissue membrane), and the outer seal portion 48 is The wound hole 55 is covered from the outside of the blood vessel wall (in vivo tissue membrane), and the connecting portion 51 is inserted through the wound hole 55.

  As shown in FIG. 3, the connecting portion 51 connects the substantially central portions of the inner seal portion 47 and the outer seal portion 48. As shown in FIG. 2, the connecting portion 51 has a narrow and narrow shape. Thereby, the wound hole 55 can be easily closed after the wound hole 55 is closed, and hemostasis can be more reliably performed.

  The outer seal portion 48 is divided into projecting pieces 49 and 50 with the vicinity of the connecting portion 51 as a boundary. The outer seal portion 48 can be deformed into a posture (see FIG. 2) folded so that the projecting pieces 49 and 50 stick to each other with a crease in the vicinity of the connecting portion 51 and an open posture (see FIG. 3). . In other words, the pair of projecting pieces 49 and 50 protrudes in a wing shape from the inner seal portion 47 via the connecting portion 51 and can be opened and closed.

  As shown in FIG. 2, the closing means 46 closes the outer seal portion 48 and superimposes the protruding pieces 49, 50, and puts the outer seal portion 48 into the first through hole 11 of the closure main body 9. While being inserted from the opening, it is held at the tip of the closure body 9.

  In such a closing means 46, it is preferable that the inner seal portion 47, the connecting portion 51, and the outer seal portion 48 are integrally formed.

  Such closing means 46 is hard enough to be punctured by the needle members 41, 41. Although it does not specifically limit as a raw material of the closing means 46, From a viewpoint of fully ensuring the piercing ease with the needle members 41 and 41, it is preferable to mainly comprise the aggregate of fibers.

  As a method of manufacturing the closing means 46 mainly with a fiber assembly, 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 closing means 46 is preferably at least partly composed of a bioabsorbable material (a material having biodegradability). By comprising with such a material, since it will be absorbed by the living body after a lapse of a predetermined time, 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.

  It is preferable that at least a part of the closing means 46 is made of a material having X-ray contrast properties. By configuring with such a material, the state of the closing means 46 in the mounting process and the state after mounting can be confirmed.

  The holding means 27 is for holding the closing means 46 at the distal end portion of the closure body 9 and preventing it from falling off. The holding means 27 is a holding suiter (within the first through hole 11 of the closure body 9). (Holding thread-like member) 28 and a lock cap 29 for holding the holding suture 28 in the closure body 9.

  The holding suturer 28 passes through the first through hole 11 of the closure body 9 in a state of passing through a part of the outer seal portion 48 of the closing means 46, folding it in two and bundling both ends, and the slide hole 19 and By pulling out through the suture outlet 20 and attaching a lock cap 29 to the suture outlet 20, the closure body 9 is held. In this case, both the projecting pieces 49 and 50 of the outer seal portion 48 of the closing means 46 are inserted into the first through hole 11 in a folded state, and the holding suture 28 is pulled to remove looseness. The closing means 46 is held at the tip of the closure body 9 without being detached by the tension of the suturer 28.

  As shown in FIGS. 1 and 2, a ring-shaped (cylindrical) anchor member 40 having a thread insertion hole is detachably attached to the tip of each needle member 41. The anchor member 40 can be pierced through the in-vivo tissue membrane and the inner seal portion 47 with the needle tip of the needle member 41.

  FIG. 3 shows a state where the needle member 41 is removed from the inner seal portion 47 after the anchor member 40 has pierced the inner seal portion 47 together with the needle tip of the needle member 41. In this state, the anchor member 40 remains on the inner seal portion 47 side. When the needle member 41 is removed from the inner seal portion 47, the hole through which the needle member 41 penetrates the inner seal portion 47 is immediately closed by the restoring force of the material of the inner seal portion 47, and the anchor member 40 passes through this hole. Since it is not possible, the needle member 41 is detached from the tip and remains on the inner seal portion 47 side.

  As shown in FIGS. 1 and 2, fixing sutures (thread-like members) 37 for fastening the closing means 46 to fix the wound holes 55 are inserted into the thread insertion holes of the anchor members 40, respectively. . The fixing suturer 37 further passes through a through hole formed in the outer seal portion 48.

  As shown in FIG. 3, a ring 39 is provided at the tip of each fixing suturer 37 via a knot 38, and this ring 39 serves as a through hole of the outer seal portion 48 and a thread insertion hole of the anchor member 40. It is inserted. That is, each fixing suturer 37 is made to penetrate the protrusions 49 and 50 of the outer seal portion 48 of the closing means 46 from the upper surface side to the lower surface side, and the anchor member 40 is inserted on the lower surface side of each protrusion 49, 50, The protrusions 49 and 50 are folded back so as to penetrate from the lower surface side to the upper surface side, and connected to the base end side of the fixing suturer 37 by a knot 38 on the upper surface side of the protrusions 49 and 50.

  For example, the knot 38 is knotted as shown in FIG. 4 or 5 and can be moved only in the direction in which the ring 39 is tightened (the direction in which the ring 39 is reduced).

  As shown in FIG. 1, a knot pusher 31 as a fastening means for fastening the fixing suturer 37 is mounted in the first through hole 11 of the closure body 9. As shown in FIG. 3, the knot pusher 31 bundles a pair of tube-like knot pusher tubes 32 and 32 inserted through the base end sides of the fixing suturers 37 and 37 and the base end portions of the knot pusher tubes 32 and 32. A tube hub 33 fixed so as to be held, and a suture hub (gripping portion) 35 to which a base end portion of a fixing suturer 37 inserted through each knot pusher tube 32 is fixed.

  The tube hub 33 is formed in a columnar shape. The tube hub 33 is provided with a pair of fitting holes 34, 34 penetrating between the upper and lower surfaces, and the base end portion of the knot pusher tube 32 is fitted into each fitting hole 34. Is integrally connected to the tube hub 33. The diameter of the tube hub 33 is set to a value that allows loose fitting in the first through hole 11 of the closure body 9.

  The suture hub 35 is formed in a cylindrical shape having a larger diameter than the tube hub 33. On the outer surface of the suture hub 35, a semicircular groove 36 having a semicircular cross section facing in the axial direction is provided so as to penetrate between the upper and lower surfaces, and the holding suturer 28 of the holding means 27 is inserted into the suture groove 36. doing. A base end portion of the fixing suturer 37 is fixed to the end surface on the distal end side of the suture hub 35 by fixing means. The diameter of the suture hub 35 is set to a value that can be slidably mounted in the first through hole 11 of the closure body 9.

  As shown in FIG. 1, the needle member 41 has a rod shape with a pointed needle tip, is slidable into the second through hole 12 and the third through hole 14 of the closure body 9, and the tip portion is first. The second through hole 12 and the third through hole 14 are mounted so as to be able to protrude and retract from the front end side openings 13 and 15.

  As shown in FIG. 1, the base end portion of each needle member 41 projects into the slide hole 19 from the base end side openings 13 and 15 of the second through hole 12 and the third through hole 14, and the pusher of the needle pusher 23. The main body 24 is integrally connected to the distal end side. Accordingly, by pressing the needle pusher 23 against the urging force of the compression spring 26 in the direction of the distal end of the closure body 9, both needle members 41, 41 move in the same direction integrally with the needle pusher 23, and each needle member The front end portion of 41 protrudes outward from the front end side openings 13 and 15 of the second through hole 12 and the third through hole 14. On the other hand, by releasing the pressing state by the needle pusher 23, the needle pusher 23 is pressed and moved in the direction away from the closure body 9 by the urging force of the compression spring 26, and the both needle members 41, 41 are integrated with the needle pusher 23. Move in the same direction, and the tip portions of both needle members 41, 41 are immersed in the second through hole 12 and the third through hole 14. That is, the needle member 41 can advance and retreat to a position protruding beyond the distal end of the apparatus main body 2 in the distal direction and a position retracted in the proximal direction.

  The anchor member 40 has a cylindrical shape, and is configured such that the fixing suturer 37 can be inserted through the inner thread insertion hole. The anchor member 40 presses the needle pusher 23 so that the distal end portion of each needle member 41 protrudes from the distal end side openings 13 and 15 of the second through hole 12 and the third through hole 14, and the protruded needle members 41 is attached to the tip. Then, by returning the needle pusher 23 to the original position in this state, the needle pusher 23 is immersed in the second through-hole 12 and the third through-hole 14 in a state of being attached to the tip portion of each needle member 41. This state is a state in which the anchor member 40 is attached to the closure body 9.

  The anchor member 40 presses the needle pusher 23 to cause the distal end portion of each needle member 41 to protrude from the distal end side openings 13 and 15 of the second through hole 12 and the third through hole 14, and the distal end portion of each needle member 41. By penetrating the inner seal portion 47 of the closing means 46, the inner seal portion 47 is penetrated integrally with each needle member 41 and arranged on the lower surface side of the inner seal portion 47. In this state, each needle member 41 is returned to the original position by the needle pusher 23, whereby each needle member 41 is pulled out from the inner seal portion 47, and the anchor member 40 is detached from the distal end portion of each needle member 41, The anchor member 40 is retained on the lower surface side of the inner seal portion 47 while being held by the fixing suturer 37.

Next, an example of a method for assembling such an in vivo tissue closing device 1 will be described.
First, the holding suture 28 is attached to the outer seal portion 48 by passing the holding suture 28 through a part of the outer seal portion 48 of the closing means 46. Then, the base end portions of the pair of fixing suiters 37 and 37 are fixed to the suture hub 35 of the knot pusher 31, and each fixing suiter 37 is inserted through the tube hub 33 and each knot pusher tube 32. Project from the tip of the tube 32. Then, the tip of each fixing suturer 37 projecting from each knot pusher tube 32 is caused to penetrate the projecting piece 49 or projecting piece 50 of the outer seal portion 48 of the closing means 46 from the upper surface side to the lower surface side. , 50, the inside of the anchor member 40 located on the lower surface side is inserted. Then, each fixing suturer 37 is folded back on the lower surface side of each projecting piece 49, 50 so that each projecting piece 49, 50 penetrates from the lower surface side to the upper surface side. A ring 39 having a knot 38 that can be tightened is formed by winding the base 37 on the base end side as shown in FIG. 4 or FIG.

  Next, as shown in FIG. 1, the projecting piece 49 and projecting piece 50 of the outer seal portion 48 of the closing means 46 are closed and polymerized, and the suture hub 35, tube hub 33 and knot pusher tubes 32, 32 of the knot pusher 31 are superposed. Are inserted into the first through-hole 11 of the closure body 9 in that order from the opening on the front end side, and both projecting pieces 49 and 50 of the closing means 46 attached to the fixing suturer 37 are inserted into the first through-hole 11. insert.

  At the same time, the holding suture 28 is inserted through the first through hole 11, pulled into the slide hole 19, pulled out from the slide hole 19 through the suture outlet 20, and a lock cap 29 is attached to the suture outlet 20. The attachment / holding suture 28 is held in the closure body 9. In this case, the holding suturer 28 is inserted into the suture groove 36 of the suture hub 35 in the first through hole 11.

  Next, the needle pusher 23 is pressed against the urging force of the compression spring 26, and both needle members 41, 41 are moved in the distal direction integrally with the needle pusher 23, so that the distal ends of both needle members 41, 41 are moved. The second through-hole 12 and the third through-hole 14 are projected from the distal end side openings 13 and 15, and the anchor members 40 and 40 are attached to the projected distal ends of the needle members 41 and 41, respectively.

  Next, the pressing state of the needle pusher 23 is released, the needle members 41 and 41 are moved in the proximal direction integrally with the needle pusher 23 by the urging force of the compression spring 26, and the distal end portions of the needle members 41 and 41 are moved. The second through-hole 12 and the third through-hole 14 are immersed from the distal end side openings 13 and 15, and both the anchor members 40 and 40 are integrated with the both needle members 41 and 41 into the second through-hole 12 and the third through-hole. 14 Immerse yourself.

  Next, by pulling the holding suture 28, loosening of the holding suture 28 is eliminated, and in this state, the lock cap 29 is attached to the suture outlet 20, thereby holding the closing means 46 at the tip of the closure body 9. Can do.

  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.

  As shown in FIG. 6, the closure 8 is inserted into the through-hole 7 of the sheath 3 already inserted into the wound hole 55 of the tissue membrane in the living body while the closing means 46 is held, and the distal end portion of the closure 8 is inserted. The closing means 46 is inserted into the blood vessel through the wound hole 55. In this case, blood in the blood vessel flows into the first through hole 11 from the opening on the front end side of the first through hole 11 of the closure body 9, and the closure body from the back flush outlet 22 through the first through hole 11. 9 Check that it flows out. After confirming blood backflushing, the closure 8 is inserted deeper, the proximal end portion of the hub 4 of the sheath 3 is inserted into the groove 17 of the hub 16 of the closure body 9, and the projection 18 on the closure body 9 side is inserted. The closure body 9 is fixed to the sheath 3 by fitting in the groove 5 on the hub 4 side.

  Next, as shown in FIG. 7, the closure 8 and the sheath 3 are pulled in the proximal direction, the distal ends thereof are removed from the blood vessel wound hole 55, and the inner seal portion 47 of the closing means 46 is removed from the blood vessel wound hole 55. It is made to contact with the inner surface side. Thereby, the blood in the blood vessel is stopped from flowing into the first through hole 11 of the closure main body 9, the outflow of blood from the back flush outlet 22 is stopped, and the inner seal portion 47 of the closing means 46 is connected to the blood vessel. It is confirmed that it is fixed on the inner surface side of the flaw hole 55.

  Next, as shown in FIG. 8, the needle pusher 23 is pressed against the urging force of the compression spring 26, the both needle members 41, 41 are moved in the distal direction, and the distal ends of the both needle members 41, 41 and The anchor members 40, 40 are projected from the distal end side openings 13, 15 of the second through hole 12 and the third through hole 14, the blood vessel wall is penetrated from the outer surface side to the inner surface side, and the inner seal portion on the inner surface side of the blood vessel wall 47 is penetrated from the upper surface side to the lower surface side, and the tip portions of both needle members 41, 41 and both anchor members 40, 40 are positioned on the lower surface side of the inner seal portion 47.

  Next, as shown in FIG. 9, the pressing state of the needle pusher 23 is released, and the both needle members 41, 41 are moved in the proximal direction integrally with the needle pusher 23 by the urging force of the compression spring 26, thereby 41 and 41 are removed from the inner seal portion 47 and the blood vessel wall, both anchor members 40 and 40 are detached from the both needle members 41 and 41, and are left (remaining) on the lower surface side of the inner seal portion 47. , 41 is immersed in the second through hole 12 and the third through hole 14 of the closure body 9. As a result, the fixing suiter 37 (ring 39) is stretched between the outer seal portion 48 and the inner seal portion 47.

  Next, the lock cap 29 is removed from the suture pull-out opening 20 of the closure main body 9, the holding state of the holding suture 28 is released, and one end of the holding suture 28 is grasped by hand and pulled to thereby hold the holding suture 28. Remove from the outer seal 48 of the closing means 46. Thereby, the holding state with respect to the closing means 46 is released, and the closing means 46 can be detached from the apparatus main body 2.

  Next, as shown in FIG. 10, when the closure body 9 and the sheath 3 are removed from the wound hole 55, the knot pusher 31 remains at the puncture site.

  Next, as shown in FIG. 11, the suture hub 35 and the tube hub 33 of the knot pusher 31 are separately grasped by hand, and the tube hub 33 and the suture hub 35 are moved away from each other. By this operation, the knots 38 and 38 of the fixing suiters 37 and 37 are gradually pushed toward the closing means 46 by the knot pusher tubes 32 and 32, and the fixing suiters 37 and 37 are moved away from the closing means 46. The rings 39 and 39 of the fixing suturers 37 and 37 are tightened, and the projecting piece 49 and the projecting piece 50 of the outer seal portion 48 of the closing means 46 abut against the outer surface side of the blood vessel wall. The blood vessel wall near the wound hole 55 is sandwiched between the seal portion 47 and the outer seal portion 48. Since the knots 38, 38 once tightened do not loosen, the wound 55 of the blood vessel can be reliably closed between the inner seal portion 47 and the outer seal portion 48 of the closing means 46, and the closed state is closed. Can be maintained.

  Next, as shown in FIG. 12, the tube hub 33, the knot pusher tubes 32 and 32, and the suture hub 35 of the knot pusher 31 are removed to leave both fixing suiters 37 and 37, and both fixing members coming out of the body. The portions of the sutures 37 and 37 are cut and removed.

  In this way, the closing means 46 can be fixed in the vascular wound 55, and the blood vessel puncture 55 can be closed to stop bleeding.

  As described above, according to the in-vivo tissue closing device 1 of the present invention, the wound hole 55 is sandwiched from the inner and outer surfaces by the inner seal portion 47 and the outer seal portion 48 having a relatively large area. The wound hole 55 can be reliably closed and hemostasis can be reliably performed. Also, the operation of closing the flaw hole 55 is extremely simple and can be performed quickly and reliably.

  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 sectional drawing which showed the whole one Embodiment of the in-vivo tissue closure apparatus by this invention. It is the perspective view which showed the whole one Embodiment of the in-vivo tissue closure apparatus by this invention. It is a perspective view of the knot pusher of FIG. It is explanatory drawing which showed an example of the knot of the fixing suture. It is explanatory drawing which showed the other example of the knot of the fixing suture. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which inserted the closure in the sheath. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which pulled the sheath and the closure and made the inner seal part of the closing means contact | abutted to the inner surface of the blood vessel. It is explanatory drawing which showed the effect | action of the biological tissue closing apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which penetrated the needle member and the anchor member to the inner seal part of the closing means. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which removed the lock cap of a holding means and removed the holding suture. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which extracted the sheath and the closure. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: The knot is pushed by a knot pusher, The explanatory drawing which showed the state which contact | abutted the outer seal part of the closure means to the outer surface of the blood vessel. is there. It is explanatory drawing which showed the effect | action of the in-vivo tissue closure apparatus of FIG. 1, Comprising: It is explanatory drawing which showed the state which removed the knot pusher and cut | disconnected the excess part of the fixing suture.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 In-vivo tissue closure apparatus 2 Apparatus main body 3 Sheath 4 Hub 5 Groove 7 Through-hole 8 Closure 9 Closure main body 10 Tapered surface 11 1st through-hole 12 2nd through-hole 13 Opening part 14 3rd through-hole 15 Opening part 16 Hub 17 Groove 18 Protrusion 19 Slide hole 20 Suture outlet 22 Back flush outlet 23 Needle pusher 24 Pusher body 25 Flange 26 Compression spring 27 Holding means 28 Holding sour 29 Lock cap 31 Not pusher 32 Not pusher tube 33 Tube hub 34 Fitting hole 35 Suture Hub 36 Suture Groove 37 Fixing Suture 38 Knot 39 Wheel 40 Anchor Member 41 Needle Member 46 Closing Means 47 Inner Sealing Portion 48 Outer Sealing Portion 49, 50 Protrusion 51 Connecting Portion 55 Wound Hole

Claims (10)

An in-vivo tissue closing device for closing a wound hole penetrating an in-vivo tissue membrane,
An inner seal portion that covers the wound hole from the inside of the biological tissue membrane; an outer seal portion that covers the wound hole from the outer side of the biological tissue membrane; and the inner seal portion and the outer portion that are inserted through the wound hole. A closing means having a connecting portion for connecting the seal portion;
An elongate apparatus main body having a holding means for detachably holding the outer seal part of the closing means at the tip part, the tip part of which can be inserted into a living tissue through the wound hole;
A plurality of long needles installed to be able to advance and retreat with respect to the device body so as to extend in a distal direction beyond the tip of the device body and in a position retracted in the proximal direction, and having a needle tip at the tip Members,
An anchor member that is detachably attached to the distal end portion of each needle member, is capable of piercing the tissue tissue and the inner seal portion with the needle tip, and has a thread insertion hole;
A thread-like member inserted into a through-hole formed in the outer seal portion and a thread insertion hole of the anchor member;
An in-vivo tissue closing device comprising: a fastening means for fastening the thread-like member.   In a state where the closing means is supported by the apparatus main body so that the inner seal portion covers the wound from the inner surface side of the in-vivo tissue membrane, the anchor member is moved forward in the distal direction. The anchor member remains in the inner seal portion by penetrating the in vivo tissue membrane and the inner seal portion together with the needle tip, and then retracting the needle member, and then the holding state of the holding means with respect to the outer seal portion After that, by tightening the thread-like member with the tightening means, the tissue tissue in the vicinity of the wound is sandwiched between the outer seal portion and the inner seal portion, and the wound hole is closed. The in-vivo tissue closure device according to claim 1, which is configured to be configured as described above.   The in-vivo tissue closing device according to claim 1 or 2, wherein at least a part of the closing means is composed of an aggregate of fibers.   The in-vivo tissue closing device according to any one of claims 1 to 3, wherein at least a part of the closing means is made of a woven fabric or a non-woven fabric.   The inner seal portion and the outer seal portion each have a plate shape, and the substantially central portions of both are connected via the connecting portion, and the outer seal portion has a crease in the vicinity of the connecting portion. The in-vivo tissue closing device according to any one of claims 1 to 4, wherein the in-vivo tissue closing device can be deformed into a folded position and an open position. On one end side of the thread-like member, a ring through which the through hole of the outer seal portion and the thread insertion hole of the anchor member are inserted, and a knot movable in one direction are formed,
The in-vivo tissue closing device according to any one of claims 1 to 5, wherein the tightening means tightens the thread-like member by moving the knot so that the ring becomes small.   The tightening means includes a plurality of tubes that are inserted through the other end side of the thread-like member, and a gripping part that is fixed to the thread-like member that protrudes from a proximal end opening of the tube, and the gripping part is attached to the tube. The in-vivo tissue closing device according to claim 6, wherein the thread-like member is tightened by pulling relatively in a proximal direction.   The holding means includes a holding thread-like member that is inserted into the apparatus main body and has a distal end connected to the outer seal part of the closing means, and holds the outer seal part by the tension of the holding thread-like member. The in-vivo tissue closing device according to any one of claims 1 to 7.   The in-vivo tissue closure device according to any one of claims 1 to 8, wherein a portion on a distal end side of the needle member can protrude / immerse from an opening formed near a distal end in the device main body. The in-vivo tissue closing device according to any one of claims 1 to 9, wherein the closing means is made of a bioabsorbable material.

Images