Background Art A minimally invasion operation which is performed by inserting a device for diagnosis or treatment such as a catheter into a blood vessel or some other living body tissue is conventionally performed widely. For example, in treatment of constriction of the coronary artery of the heart, it is necessary to insert a device such as a catheter into a blood vessel in order to perform the therapy treatment against the constriction.

Such insertion of a catheter into a blood vessel is normally performed through a puncture formed by dissecting the femoral region. Accordingly, after the therapy treatment is completed, it is necessary to stanch the bleeding through the puncture. However, since the blood pressure upon bleeding (bleeding blood pressure) from the femoral artery is high, such a severe work as to continue to hold down a required part for a long period of time with a finger of a hand is required for a person involved in the medical treatment.

In recent years, in order to perform such a stanching work readily and with certainty, a suturing device for being inserted through a wound hole to suture a hole formed in a blood vessel has been developed. For example, Japanese Translations of PCT for Patent No. Hei 8-504618 discloses a suturing device configured such that a member which can be expanded into a shape of a basket is provided at an end portion of the suturing device. Upon suturing, the member is inserted into a blood vessel and expanded into a shape of a basket, and then a suture needle is inserted, whereafter the member expanded in the shape of a basket is closed to catch the needle and then the end portion of the device is pulled off.

However, the suturing device having such a configuration as described above has a problem in that the reliability in catching the needle is low. Further, after a thread for suturing is threaded once through the needle, it is necessary to perform a replacing work of the thread.

Therefore, the suturing device has another problem in that time and labor are required for the suturing.

Meanwhile, as a living body tissue closing device, a device wherein a hard seal portion and collagen sponge are connected to each other by a thread is disclosed in Japanese Patent No. 2,562, 007.

As an operation method of this device, the distal end of the body element of the device is inserted into a blood vessel through a wound hole, and the seal portion is expanded. Then, while the body element is pulled off slowly, the seal portion is placed into contact with the wound hole and peripheral tissues of the wound hole. If the body element is pulled off while the seal portion catches the wound hole, then the collagen sponge is expanded in the tissues on the wound hole from the distal end of the body element. Then, the body element is pulled off to the outside of the body and the thread which connects the seal portion and the collagen sponge is pulled to advance a knot provided in advance to draw the seal portion and the collagen sponge toward each other to stanch the bleeding. Finally, the thread is cut, thereby ending the operation.

However, in the living body tissue closing device having such a configuration as described above, the collagen sponge is propelled toward the wound hole from the body element having a diameter substantially same as that of the wound hole. Therefore, the living body tissue closing device has a problem in that the collagen sponge is inserted into the blood vessel.

Further, the living body tissue closing device has a problem also in that the collagen sponge is sometimes expanded within the distal end of the body element and does not come out of the body element.

Further, since the seal portion and the collagen sponge are connected to each other by the thread, one of the seal portion and the collagen sponge is displaced in any direction with respect to the other. Therefore, the angle changes to an unexpected direction, and operation of the living body tissue closing device is difficult.

Meanwhile, Japanese Patent No. 3,133, 059 discloses a device wherein a closing member to which a thread is attached is disposed into a blood vessel and an ring (locking member) is slipped to move along the thread.

Then, the ring locks the thread outside the blood vessel to close up the hole formed in the blood vessel.

According to the device described, the closing member is secured to the wall of the blood vessel by fixing the ring to the thread by some means.

However, with the device having such a configuration as described above, since an operation of securing the ring to the thread within subcutaneous tissues, the securing operation is difficult.

Further, since the outer diameter of the ring need be a dimension with which the ring can be inserted into the wound hole, the ring cannot be avoided to be formed in a small size, and there is the possibility that the ring may drop into the blood vessel through the hole formed in the blood vessel.

Further, since the closing member and the ring are connected to each other by the thread, one of the closing member and the ring is displaceable in any direction with respect to the other. Therefore, the angle changes to an unexpected direction, and the living body tissue closing device is difficult to operate.

Disclosure of Invention It is an object of the present invention to provide a tissue closure and a tissue closing device which can close an opening formed in a tissue such as a wall of a blood vessel readily and with certainty to fully stanch the bleeding and are high in safety.

In order to attain the object described above, according to an aspect of the present invention, there is provided a tissue closure for closing an opening which penetrates a tissue membrane, including, a seal portion having a flat face portion for covering the opening and a surrounding portion of the opening from one side of the tissue membrane, a deformation portion capable of expanding and contracting in two directions substantially perpendicular to each other, and a fastener portion positioned on the inner side of the deformation portion for retaining the deformation portion in a predetermined form, the deformation portion having an opening portion movable relative to the fastener portion and capable of accepting the fastener portion and a fixed portion integrated with the fastener portion and immovably with respect to the fastener portion.

With the tissue closure, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety. In other words, the opening can be closed readily and with certainty, and the bleeding can be stanched completely.

In the tissue closure of the present invention, preferably the seal portion and the deformation portion are formed integrally from the same material.

In the tissue closure of the present invention, preferably the deformation portion has a shape of a framework.

In the tissue closure of the present invention, preferably the deformation portion has a quadrangular shape formed integrally from four links and deforms such that two corner portions at diagonal positions of the quadrangular shape move toward and away from each other.

In the tissue closure of the present invention, preferably the fastener portion is formed in such a manner as to control the distance between the two corner portions.

In the tissue closure of the present invention, preferably the fastener portion is formed in such a manner as to be capable of controlling the distance between the two corner portions at a plurality of stages.

In the tissue closure of the present invention, preferably the fastener portion is formed in such a manner as to be capable of controlling the degree of deformation of the deformation portion at a plurality of stages.

In the tissue closure of the present invention, preferably the fastener portion is formed in such a manner as to allow deformation of the deformation portion in a direction in which the degree of deformation of the deformation portion increases but block deformation of the deformation portion in another direction in which the degree of deformation of the deformation portion decreases.

In the tissue closure of the present invention, preferably the fastener portion has at least one pawl capable of being inserted into the opening portion and engaged with the deformation portion.

In the tissue closure of the present invention, preferably the seal portion has a shape of a plate.

In the tissue closure of the present invention, preferably the deformation portion is connected for rocking motion to the seal portion.

In the tissue closure of the present invention, preferably the fastener portion is formed integrally with the seal portion and the deformation portion from the same material.

In the tissue closure of the present invention, preferably the fastener portion and the deformation portion are individually inclined with respect to the seal portion.

In the tissue closure of the present invention, preferably the tissue closure is made of a bioabsorbable material.

In the tissue closure of the present invention, preferably the tissue closure has formed therein a hole through which a guide wire is to pass through.

In the tissue closure of the present invention, preferably the fastener portion has formed therein a hole through which a string for pulling the tissue closure is to be threaded.

In the tissue closure of the present invention, preferably the tissue membrane is a blood vessel wall, and the one side is an inner surface of the blood vessel wall.

According to another aspect of the present invention, there is provided a tissue closure for closing an opening which penetrates a tissue membrane, including, a seal portion having a shape of a plate for covering the opening and a surrounding portion of the opening from one side of the tissue membrane, a deformation portion having a shape of a framework deformable between a contracted form in which the deformation portion extends in a direction substantially perpendicular to the seal portion and is contracted in a direction substantially parallel to the seal portion and an expanded form in which the deformation portion is contracted in the direction substantially perpendicular to the seal portion and is expanded in the direction substantially parallel to the seal portion, and a fastener portion for retaining the deformation portion when the deformation portion is deformed to a predetermined form between the contracted form and the expanded form.

With the tissue closure, a stanching operation for an opening formed in a tissue membrane can be performed readily with a higher degree of accuracy and with a high degree of safety. In other words, the opening can be closed readily and with certainty, and the bleeding can be stanched completely.

In the tissue closure of the present invention, preferably the deformation portion has a shape like a pantograph.

In the tissue closure of the present invention, preferably the deformation portion has a polygonal annular shape formed by bending a belt-like member by a plural number of times.

In the tissue closure of the present invention, preferably the deformation portion has a quadrangular shape formed integrally from four links and deforms such that two corner portions at diagonal positions of the quadrangular shape move toward and away from each other.

Preferably, the tissue closure of the present invention further includes a connecting portion for connecting the seal portion and the deformation portion to each other.

In the tissue closure of the present invention, preferably the deformation portion has a projection provided on the outer side thereof on the seal portion side and projecting toward the seal portion side.

With the tissue closure, the projection is positioned in the proximity of the opening closed with the tissue closure, and the opening is tightened strongly by the projection. Consequently, the bleeding can be stanched with a higher degree of certainty.

Further, even if failure in stanching (for example, when the blood vessel wall or the subcutaneous tissue is so hard that the deformation portion cannot be expanded or the like) occurs and manual compression becomes required and force in the direction in which the tissue closure is inserted transcutaneously into the blood vessel is applied to the tissue closure by the manual compression, a drop (omission) of the tissue closure into the blood vessel can be prevented by the projection. This enhances the safety.

According to a further aspect of the present invention, there is provided a tissue closure having a seal portion for covering an opening which penetrates a tissue membrane and a surrounding portion of the opening from one side of the tissue membrane, the tissue closure being adapted to close the opening, said tissue closure comprising: at least at a portion having a framework body deformable between a contracted form in which the portionis extended in a direction substantially perpendicular to a reference plane and is contracted in a direction substantially parallel to the reference plane and an expanded form in which the portion is contracted in the direction substantially perpendicular to the reference plane and is expanded in the direction substantially parallel to the reference plane.

With the tissue closure, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety. In other words, the opening can be closed readily and with certainty, and the bleeding can be stanched completely.

In the tissue closure of the present invention, preferably the tissue closure has a fastener portion for retaining said portion when the framework body is placed into a predetermined form between the contracted form and the expanded form.

According to a still further aspect of the present invention, there is provided a tissue closure for closing an opening which penetrates a tissue membrane of a living organism lumen, including, a seal portion for being inserted into the living organism lumen to cover the opening and a surrounding portion of the opening from an inner surface of the tissue membrane, the seal portion being formed such that the longest portion thereof has a length set smaller than the inner diameter of the living organism lumen into which the seal portion is inserted.

With the tissue closure, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety. In other words, the opening can be closed (closed up) readily and with certainty, and the bleeding can be stanched completely.

Preferably, the tissue closure of the present invention further includes a deformation portion deformable between a first form in which the deformation portion can pass through the opening and a second form in which the deformation portion can cooperate with the seal portion to sandwich the tissue membrane therebetween from the other side of the tissue membrane.

Preferably, the tissue closure of the present invention further includes a fastener portion for retaining the deformation portion in the second form.

In the tissue closure of the present invention, preferably the seal portion is connected for turning motion around an axis of turning motion to the deformation portion.

In the tissue closure of the present invention, preferably the seal portion has a shape of a plate, and the length of the longest portion of the seal portion is 6 mm or less.

According to a yet further aspect of the present invention, there is provided a tissue closure for closing an opening which penetrates a tissue membrane, including, a seal portion for covering the opening and a surrounding portion of the opening from one side of the tissue membrane, and a retaining portion for cooperating with the seal portion to sandwich the tissue membrane therebetween from the other side of the tissue membrane and retain the seal portion on the one side, the retaining portion having the seal portion connected thereto for turning motion around an axis of turning motion.

With the tissue closure, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety. In other words, the opening can be closed readily and with certainty, and the bleeding can be stanched completely.

In the tissue closure of the present invention, preferably a connecting portion between the seal portion and the retaining portion has flexibility such that, as the connecting portion is bent, the seal portion is turned.

In the tissue closure of the present invention, preferably the seal portion has a shape of a plate, and the retaining portion has a shape of a framework deformable between a first form in which the retaining portion can pass through the opening and a second form in which the retaining portion can cooperate with the seal portion to sandwich the tissue membrane therebetween from the other side of the tissue membrane.

According to a yet further aspect of the present invention, there is provided a tissue closing device, including, any tissue closure of the present invention, and an elongated arrangement device for removably retaining, at a distal end portion thereof, the tissue closure, the tissue closure being adapted to be arranged into a living organism and close an opening which penetrates a tissue membrane.

With the tissue closing device, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety.

In other words, the opening can be closed (closed up) readily and with certainty, and the bleeding can be stanched completely.

Preferably, the tissue closing device of the present invention further includes displacement means for displacing the seal portion so that the seal portion may extend substantially in parallel to an axial direction of the arrangement device.

In the tissue closing device of the present invention, preferably the displacement means has a contacting portion provided at the distal end portion of the arrangement device for contacting with a face of the seal portion on the deformation portion side.

In the tissue closing device of the present invention, preferably the tissue closure includes a deformable deformation portion adjacent the seal portion, and the tissue closing device further includes a retainer for retaining the deformation portion of the tissue closure at the distal end portion of the arrangement device.

In the tissue closing device of the present invention, preferably the retainer includes a deformation portion pulling means for pulling the deformation portion to a proximal end side of the arrangement device.

According to a yet further aspect of the present invention, there is provided a tissue closing device for closing an opening which penetrates a tissue membrane, including, an elongated body element having a distal end portion capable of passing though the opening, a tissue closure removably mounted at the distal end portion of the body element and capable of passing through the opening together with the distal end portion of the body element to close the opening, and a deformation means, the tissue closure including, a seal portion for covering the opening and a surrounding portion of the opening from one side of the tissue membrane, a deformation portion having a shape of a framework deformable to a first form in which the deformation portion can pass through the opening and deformable by the deformation means to a second form in which the deformation portion cooperates with the seal portion to sandwich the tissue membrane therebetween from the opposite side of the tissue membrane, and a fastener portion for retaining the deformation portion in the second form.

With the tissue closing device, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety.

In other words, the opening can be closed (closed up) readily and with certainty, and the bleeding can be stanched completely.

According to a yet further aspect of the present invention, there is provided a tissue closing device for closing an opening which penetrates a tissue membrane, including, an elongated body element having a distal end portion capable of passing though the opening, a tissue closure removably mounted at the distal end portion of the body element and capable of passing through the opening together with the distal end portion of the body element to close the opening, and deformation means, the tissue closure including, a seal portion for covering the opening and a surrounding portion of the opening from one side of the tissue membrane, a deformation portion deformable to a first form in which the deformation portion can pass through the opening and deformable by the deformation means to a second form in which the deformation portion cooperates with the seal portion to sandwich the tissue membrane therebetween from the opposite side of the tissue membrane, and a fastener portion for retaining the deformation portion in the second form, the seal portion and the deformation portion being formed integrally from the same material.

With the tissue closing device, a stanching operation for an opening formed in a tissue membrane such as a blood vessel wall can be performed readily with a higher degree of accuracy and with a high degree of safety.

In other words, the opening can be closed readily and with certainty, and the bleeding can be stanched completely.

In the tissue closing device of the present invention, preferably the deformation portion has a shape of a framework.

In the tissue closing device of the present invention, preferably the deformation portion has an opening portion into which at least part of the fastener portion can be inserted.

In the tissue closing device of the present invention, preferably the fastener portion has at least one pawl capable of being inserted into the opening portion and engaged with the deformation portion.

In the tissue closing device of the present invention, preferably the deformation portion has a quadrangular shape formed integrally from four links and deforms such that two corner portions at diagonal positions of the quadrangular shape move toward and away from each other.

In the tissue closing device of the present invention, preferably the fastener portion is formed in such a manner as to control the distance between the two corner portions.

In the tissue closing device of the present invention, preferably the fastener portion is formed in such a manner as to be capable of controlling the distance between the two corner portions at a plurality of stages.

In the tissue closing device of the present invention, preferably the fastener portion is formed in such a manner as to be capable of controlling the degree of deformation of the deformation portion at a plurality of stages.

In the tissue closing device of the present invention, preferably the fastener portion is formed in such a manner as to allow deformation of the deformation portion in a direction in which the degree of deformation of the deformation portion increases but block deformation of the deformation portion in another direction in which the degree of deformation of the deformation portion decreases when the deformation portion is in the second form.

In the tissue closing device of the present invention, preferably the seal portion has a shape of a plate.

In the tissue closing device of the present invention, preferably the deformation portion is connected for rocking motion to the seal portion.

In the tissue closing device of the present invention, preferably the fastener portion is formed integrally with the seal portion and the deformation portion from the same material.

In the tissue closing device of the present invention, preferably the fastener portion and the deformation portion are individually inclined with respect to the seal portion.

In the tissue closing device of the present invention, preferably the tissue closure is made of a bioabsorbable material.

In the tissue closing device of the present invention, preferably the tissue closure has formed therein a hole through which a guide wire is to pass through.

Preferably, the tissue closing device of the present invention further includes pulling means for pulling the tissue closure, the deformation portion being deformed by the deformation means while the tissue closure is being pulled by the pulling means.

In the tissue closing device of the present invention, preferably the pulling means is a string.

In the tissue closing device of the present invention, preferably the fastener portion has a hole through which the string is to be threaded.

In the tissue closing device of the present invention, preferably the deformation means presses the deformation portion to deform the deformation portion into the second form.

In the tissue closing device of the present invention, preferably the deformation means is, at least at a portion thereof, a tubular member provided on the body element.

In the tissue closing device of the present invention, preferably the tissue membrane is a blood vessel wall, and the one side is an inner surface of the blood vessel wall while the opposite side is an outer surface of the blood vessel wall.

Brief Description of Drawings FIG. 1 is a perspective view showing a first embodiment of a tissue closing device of the present invention; FIG. 2 is a side elevational view, a perspective view and a partial plan view showing a tissue closure of the tissue closing device shown in FIG. 1; FIG. 3 is a side elevational view showing different examples of a configuration of the tissue closure of the tissue closing device shown in FIG. 1 ; FIG. 4 is a side elevational view and a perspective view showing further different examples of a configuration of the tissue closure of the tissue closing device shown in FIG. 1 ; FIG. 5 is a side elevational view showing a still further different example of a configuration of the tissue closure of the tissue closing device shown in FIG.

1; FIG. 6 is a sectional view illustrating an action (operation) of the tissue closing device shown in FIG. 1; FIG. 7 is a sectional view illustrating another action (operation) of the tissue closing device shown in FIG. 1; FIG. 8 is a sectional view illustrating a further action (operation) of the tissue closing device shown in FIG. 1; FIG. 9 is a sectional view illustrating a still action (operation) of the tissue closing device shown in FIG. 1; FIG. 10 is a sectional view illustrating a yet further action (operation) of the tissue closing device shown in FIG. 1; FIG. 11 is a sectional view illustrating a yet further action (operation) of the tissue closing device shown in FIG. 1 ; FIG. 12 is a sectional view illustrating a yet action (operation) of the tissue closing device shown in FIG. 1; FIG. 13 is a perspective view showing a second embodiment of a tissue closing device of the present invention; FIG. 14 is a perspective view showing a tissue closure of the tissue closing device shown in FIG. 13; FIG. 15 is a perspective view showing another example of a configuration of the tissue closure of the tissue closing device shown in FIG. 13; FIG. 16 is a sectional view illustrating an action (operation) of the tissue closing device shown in FIG.

13 ; FIG. 17 is a sectional view illustrating an action (operation) of the tissue closing device shown in FIG.

13 ; FIG. 18 is a perspective view showing a third embodiment of a tissue closing device of the present invention; FIG. 19 is a perspective view illustrating an action (operation) of the tissue closing device shown in FIG. 18; and FIG. 20 is a sectional view illustrating an action (operation) of the tissue closing device shown in FIG. 18.

Best Mode for Carrying out the Invention In the following, a tissue closure and a tissue closing device of the present invention are described in detail based on preferred embodiments thereof shown in the accompanying drawings.

<First Embodiment> First, a first embodiment of the living body tissue closing device of the present invention is described.

FIG. 1 is a perspective view showing a first embodiment of a living body tissue closing device of the present invention; FIG. 2 is a side elevational view (a), a perspective view (b) and a partial plan view (c) showing a living body tissue closure of the living body tissue closing device shown in FIG. 1; FIG. 3 is a side elevational view showing different examples of a configuration of the living body tissue closure of the living body tissue closing device shown in FIG. 1; FIG. 4 is a side elevational view and a perspective view showing further different examples of a configuration of the living body tissue closure of the living body tissue closing device shown in FIG. 1; FIG. 5 is a side elevational view showing a still further different example of a configuration of the living body tissue closure of the living body tissue closing device shown in FIG. 1; and FIGS. 6 to 12 are sectional views individually illustrating action (operation) of the living body tissue closing device shown in FIG. 1.

It is to be noted that, for the convenience of description, in FIGS. 1 and 6 to 11, the left lower side is referred to as"distal end"and the right upper side (hand side) is referred to as"proximal end". Further, in FIGS. 2 to 5 and 12, although the upper side of the living body tissue closing device as a whole in the figures is the"proximal end"and the lower side is the"distal end", as regards a clip (living bodytissue closure) 4, the upper side in the figures is referred to as"distal end"and the lower side is referred to as"proximal end".

The living body tissue closing device 1 shown in the figures is a device for closing a transdermally penetrating wound hole (opening which penetrates a living body tissue membrane) which is formed, for example, in a living organism lumen such as a blood vessel, an internal organ of a living organism or a living body tissue membrane such as an internal tissue of a living organism.

As shown in FIGS. 7 and 8, the living body tissue closing device 1 includes an elongated body element 2, and a clip 4 removably mounted at the distal end portion of the body element 2 and serving as a living body tissue closure (closing up section) for closing a wound hole which penetrates a living body tissue membrane. The living body tissue closing device 1 further includes a thread (thread-like member) (string member) 8 serving as pulling means for pulling the clip 4.

As shown in FIGS. 1,6 and 7, the body element 2 includes a sheath 5 having a through-hole 51 extending through a central portion thereof in an axial direction, and an elongated feeding and deformation means (delivery device) 3 removably mounted on the sheath 5. Upon stanching operation (operation of closing a wound hole), the distal end portions of the sheath 5 and feeding and deformation means 3 and the clip 4 individually penetrate the wound hole. In other words, they are inserted into a lumen (living organism lumen) of a living organism such as a blood vessel through the wound hole.

The sheath 5 has a substantially cylindrical shape and has a hub 52 at the proximal end portion thereof. A groove 53 is formed along a circumferential direction on an outer periphery of the hub 52.

For the sheath 5, for example, a sheath (introducer sheath) dwelling after treatment (PCI} performed using a catheter or after treatment of a diagnosis (CAG) may be used, or a sheath for exclusive use for the living body tissue closing device 1 may be used.

It is to be noted that, while, in the present embodiment, the sheath 5 is included in components of the body element 2, according to the present invention, the sheath 5 may not be included in components of the body element 2.

The feeding and deformation means 3 includes a covered tube (tubular member) 6, a pusher tube (tubular member) 7, a thread anchoring cap (thread retaining member) 9, a guide wire 11 secured at one end side thereof to the thread anchoring cap 9, and a stopper 12. Of the feeding and deformation means 3, the covered tube 6 and the pusher tube 7 constitute principal part of feeding means for feeding the clip 4 and deformation means for pressing a deformation portion 42 of the clip 4 hereinafter described to deform the deformation portion 42 into a second form hereinafter described.

The covered tube 6 includes a tube body 61 and a hub 62 provided at the proximal end portion of the tube body 61. The clip 4 is removably mounted (retained) at the distal end portion of the covered tube 6. In this instance, the clip 4 is mounted such that the deformation portion 42 thereof hereinafter described is retained in a lumen at the distal end portion of the covered tube 6.

The hub 62 has a cylindrical tubular portion 621.

A rib 622 capable of engaging with the groove 53 formed on the hub 52 of the sheath 5 is formed along a circumferential direction on an inner circumferential face of the tubular portion 621. Further, a groove 623 is formed along a circumferential direction on an outer circumferential face of the hub 62.

The inner diameter of the tubular portion 621 of the hub 62 is a little greater than the outer diameter of the hub 52 of the sheath 5, and the outer diameter of the tube body 61 is a little smaller than the inner diameter of the sheath 5. Consequently, the tube body 61 of the covered tube 6 can be inserted into the sheath 5 while the hub 52 of the sheath 5 can be inserted into the tubular portion 621 of the hub 62 of the covered tube 6, and the rib 622 of the hub 62 can be engaged with the groove 53 of the hub 52. Where the rib 622 is engaged with the groove 53, one of the sheath 5 and the covered tube 6 is blocked from coming off the other, and this facilitates operation.

The pusher tube 7 includes a tube body 71 and a hub 72 provided at the proximal end portion of the tube body 71. The pusher tube 7 pushes out the clip 4 mounted at the distal end portion of the covered tube 6 from the covered tube 6 so as to be released from the covered tube 6.

The hub 72 has a cylindrical tubular portion 721.

A rib 722 capable of engaging with the groove 623 formed on the tube body 61 of the covered tube 6 is formed along a circumferential direction on an inner circumferential face of the tubular portion 721.

The outer diameter of the distal end portion of the hub 72 is smaller than the outer diameter of the tubular portion 721. A rib (flange) 723 is formed in a circumferential direction on an outer circumferential face at the proximal end of the hub 72.

The inner diameter of the tubular portion 721 of the hub 72 is a little greater than the outer diameter of the hub 62 of the covered tube 6, and the outer diameter of the tube body 71 is a little smaller than the inner diameter of the covered tube 6. Consequently, the tube body 71 of the pusher tube 7 can be inserted into the covered tube 6 while the hub 62 of the covered tube 6 can be inserted into the tubular portion 721 of the hub 72 of the pusher tube 7, and the rib 722 of the hub 72 can be engaged with the groove 623 of the hub 62. With the rib 722 is engaged with the groove 623, thereby coming out of one of the covered tube 6 and the pusher tube 7 from the other is blocked, and this facilitates operation.

The thread anchoring cap 9 is removably mounted on the hub 72 of the pusher tube 7.

The thread anchoring cap 9 has a cylindrical tubular portion 91. A groove 92 capable of engaging with the rib 723 formed on the hub 72 of the pusher tube 7 is formed along a circumferential direction on an inner circumferential face of the tubular portion 91.

The guide wire 11 is secured at one end thereof in the tubular portion 91 of the thread anchoring cap 9.

If the thread 8 is disposed between the thread anchoring cap 9 and the hub 72 of the pusher tube 7 and the thread anchoring cap 9 is mounted on the hub 72 until the rib 723 is engaged with the groove 92, then coming out of the thread anchoring cap 9 from the hub 72 of the pusher tube 7 is blocked and the thread 8 is sandwiched between and retained by the tubular portion 91 of the thread anchoring cap 9 and the rib 723 of the hub 72.

The stopper 12 is removably mounted on the tube body 71 of the pusher tube 7.

The stopper 12 includes a substantially C-shaped attaching portion 121 and a gripping portion 122. The stopper 12 is mounted on the tube body 71 (position indicated by an allow mark of a broken line in FIG. 1) in the proximity of the hub 72 by fitting the tube body 71 of the pusher tube 7 into the attaching portion 121.

As shown in FIGS. 1 and 2, the clip (living bodytissue closure) 4 includes a seal portion 41, a deformation portion (retaining portion) 42 deformable between a first form and a second form, and a fastener portion 43 for retaining the deformation portion 42 in the second form. Preferably, the seal portion 41, deformation portion 42 and fastener portion 43 are formed integrally from the same material.

The seal portion 41 is a member having a flat face portion (flat face) for covering a wound hole and a surrounding portion of the wound hole (portion of a living body tissue membrane including the wound hole) from one side (inner surface) of the living body tissue membrane, and has a shape of a plate (of a substantially rectangular shape as viewed in plan).

The deformation portion 42 has a shape of a framework which can be deformed from a basic form (basic shape) to a first form in which it can pass through a wound hole and a second form in which it can cooperate with the seal portion 41 to sandwich a living body tissue membrane therebetween from the other side (outer surface) of the living body tissue membrane. The deformation portion 42 cooperates with the seal portion 41 to sandwich the living body tissue membrane therebetween from the other side of the living body tissue membrane to retain (hold) the seal portion 41 to the one side of the living body tissue membrane. Accordingly, the deformation portion 42 forms retainer for cooperating with the seal portion 41 to sandwich a living body tissue membrane therebetween from the other side of the living body tissue membrane to retain the seal portion to the one side.

Where the living body tissue membrane is a blood vessel wall (living organism lumen wall), the one side is the inner surface of the blood vessel wall (living organism lumen wall) while the other side is the outer surface of the blood vessel wall (living organism lumen wall).

Here, in the present embodiment, the deformation portion 42 has a quadrangular shape (quadrangular framework) like a pantograph formed from four links connected integrally to each other. Of the two corner portions 421 and 422 at the diagonal positions in the upward and downward direction in FIG. 2, the lower side corner portion 422 (on the seal portion 41 side) in FIG. 2 is connected to the seal portion 41 and serves as a fixed portion which cannot move (immovably) relative to the seal portion 41 or the fastener portion 43.

Consequently, the deformation portion 42 is deformed such that the corner portion 421 and the corner portion 422 move toward and away from each other.

Accordingly, the deformation portion 42 can be deformed to expand or contract in two directions perpendicular to each other and besides can rock with respect to the seal portion 41 (turn around one axis of turning motion) as the four corner portions (corner) bend like articulations. In other words, the seal portion 41 can rock (turn around one axis of turning motion) with respect to the deformation portion 42. In this instance, the connecting portion between the seal portion 41 and the corner portion 422 of the deformation portion 42 has flexibility, and as the connecting portion bends (is elastically deformed), the seal portion 41 turns.

Further, the upper face (surface on the opposite side to the seal portion 41) of the corner portion 421 on the upper side in FIG. 2 (on the opposite side to the seal portion 41) from between the two corner portions 421 and 422 exhibits a substantially flat face (flattened face).

A substantially H-shaped slit 424 is formed in the corner portion 421 as shown in (c) of FIG. 2. The slit 424 is an opening extending through the framework-shaped deformation portion 42, and at least part of the fastener portion 43. can be inserted (fitted) (the fastener portion 43 can be received) into the corner portion 421.

The fastener portion 43 has a bar-like shape. The fastener portion 43 is positioned within the framework of the deformation portion 42 and connected at the proximal end portion thereof (lower side end portion in (a) of FIG. 2) to the inner surface of the corner portion 422 (the fastener portion 43 connects the seal portion 41 via the corner portion 422).

Consequently, the fastener portion 43 can rock (turn around a single axis of turning motion) together with the deformation portion 42 with respect to the seal portion 41. In other words, the seal portion 41 rocks (turns around a single axis of turning motion) with respect to the deformation portion 42 and the fastener portion 43.

A plurality of (four in the example shown) pawls 431 are formed on the both sides of the fastener portion 43 in the leftward and rightward direction in (a) of FIG.

2. The pawls 431 are juxtaposed in a spaced relationship by a predetermined distance from each other in the longitudinal direction of the fastener portion 43 (upward and downward direction in (a) of FIG. 2).

If the above-described feeding and deformation means 3 (body element 2) is moved in a direction toward the distal end thereof, then the distal end portions of the covered tube 6 and the pusher tube 7 are brought into contact with an upper face 423 of the corner portion 421 of the deformation portion 42 or with part of an upper face of the deformation portion 42 around the upper face 423 from the upper side in (a) of FIG. 2. Thus, the corner portion 421 of the deformation portion 42 is pressed to the lower side in (a) of FIG. 2 by the covered tube 6 and the pusher tub 7. At this time, the fastener portion 43 is positioned within the pusher tube 7 and does not make an obstacle (refer to FIG. 10).

Consequently, the corner portion 421 of the deformation portion 42 moves to the lower side in (a) of FIG. 2. Thus, the upper side end portion of the fastener portion 43 in (a) of FIG. 2 and the uppermost side ones of the pawls 431 of the fastener portion 43 in (a) of FIG. 2 pass through the slit 424 formed in the corner portion 421 (is inserted into the slit 424) and are brought into engagement with the corner portion 421 (refer to FIG. 10).

Even if the pushing by the covered tube 6 and the pusher tube 7 is canceled in this state, the shape of the deformation portion 42 is maintained. Further, even if the corner portion 421 of the deformation portion 42 is pushed to the upper side in (a) of FIG. 2, the shape of the deformation portion 42 is maintained.

It is to be noted that, as hereinafter described, the operation described above is performed while the fastener portion 43 of the clip 4 is being pulled by the thread 8.

If the feeding and deformation means 3 (body element 2) is further moved in the direction toward the distal end thereof, then the corner portion 421 of the deformation portion 42 is further pressed to the lower side in (a) of FIG. 2 by the covered tube 6 and the pusher tube 7. well, Consequently, the corner portion 421 of the deformation portion 42 further moves to the lower side in (a) of FIG. 2 while the pawls 431 of the fastener portion 43 successively pass through the slit 424 formed in the corner portion 421 (inserted into the slit 424) until the lowermost side ones of the pawl 431s in (a) of FIG. 2 are engaged finally with the corner portion 421 (refer to FIGS.

11 and 12).

Similarly as described above, even if the pushing by the covered tube 6 and the pusher tube 7 is cancelled in this state, and even if the corner portion 421 of the deformation portion 42 is pushed to the upper side in (a) of FIG. 2, the shape of the deformation portion 42 is maintained. This similarly applies also to an intermediate stage.

In this manner, the deformation portion 42 is deformed such that the corner portion 421 and the corner portion 422 approach each other to establish the second form in which the deformation portion 42 cooperates with the seal portion 41 to sandwich a living body tissue membrane therebetween to close a wound hole, and the pawls 431 are engaged with the corner portion 421 to maintain the second form.

In this manner, in the second form of the deformation portion 42, deformation of the deformation portion 42 in a direction in which the degree of deformation of the deformation portion 42 decreases is blocked by the fastener portion 43 while deformation in the other direction in which the degree of deformation of the deformation portion 42 increases is permitted. Thus, the degree of deformation of the deformation portion 42 can be controlled (adjusted) to a plurality of stages. In particular, in the second form of the deformation portion 42, deformation of the deformation portion 42 in the direction in which the corner portion 421 and the corner portion 422 are spaced away from each other is blocked by the fastener portion 43 whereas deformation of the deformation portion 42 in the other direction in which the corner portion 421 and the corner portion 422 move toward each other is permitted, and the distance between the two corner portions 421 and 422 can be controlled (adjusted) to a plurality of stages. Consequently, the living body tissue closing device 1 can apply with various conditions such as, for example, a person who has a thick living body tissue membrane, a person who has a thin living body tissue membrane, a person who has a hard living body tissue membrane, and a person who has a soft living body tissue membrane.

Further, a hole (through-hole) 432 through which the thread 8 is to be threaded is formed at the distal end portion of the fastener portion 43.

As shown in FIGS. 1 and 6, the thread 8 passes through the slit 424 of the corner portion 421 of the deformation portion 42 from the upper side in FIG. 1, through the hole 432 of the fastener portion 43 and further through the slit 424 from the lower side in FIG. 1.

In this state, the opposite end portions of the thread 8 are threaded through the inside of the pusher tube 7 and pulled out to the outside from the proximal end portion of the pusher tube 7. Then, in this state, the thread anchoring cap 9 is mounted on the hub 72, whereupon the opposite end portions of the thread 8 are sandwiched (retained) between the thread anchoring cap 9 and the hub 72, whereby the opposite end portions of the thread 8 can be retained at the proximal end portion of the pusher tube 7. In other words, the thread 8 has the fastener portion 43 retained at an end portion thereof, and in this state, the thread 8 is retained at the other end portion thereof to the proximal end portion of the pusher tube 7.

As shown in FIGS. 1 and 2, a hole (through-hole) 425 through which the guide wire 11 is to be passed through is formed in the deformation portion 42 in the proximity of the corner portion 422.

Further, a hole (through-hole) 411 through which the guide wire 11 is to be passed through is formed in the seal portion 41. The hole 411 is open at an end thereof to a left side end portion of the seal portion 41 in (b) of FIG. 2 and is open at the other end thereof to the proximity of the hole 425 of the upper surface of the seal portion 41 in (b) of FIG. 2.

As shown in FIG. 6, the guide wire 11 is passed through the slit 424 at the corner portion 421 of the deformation portion 42, the hole 425 in the deformation portion 42 and the hole 411 in the seal portion 41.

The clip 4 is preferably formed, at least at part thereof, from a bioabsorbable material, and, particularly preferably, the entire clip 4 is formed from a bioabsorbable material. In this instance, since the clip 4 is absorbed by a living organism after a predetermined interval of time and does not finally remain in the living organism, an influence on the human body can be eliminated.

As a bioabsorbable material, for example, a simple substance of polylactic acid, polyglycolic acid, or polydioxanon or a complex of them can be listed.

It is to be noted that, as a component material of the clip 4, not only a bioabsorbable material but also a biocompatible material such as a resin or a metal can be used.

Further, the clip 4 is preferably made of a material superior in hinge characteristic as a physical property required particularly for the deformation function of the deformation portion 42. More specifically, a material having a tensile strength of 100 to 500 (Kg/cm2), an elongation of 50 to 800% and a tensile modulus of 5 to 25 (x 103 Kg/cm2) is preferably used.

Where the physical property values specified are satisfied, the clip 4 is superior in hinge characteristic and the deformation portion 42 has a desired deformation capability.

The seal portion 41 and the deformation portion 42 which are components of the clip 4 are preferably formed integrally from the bioabsorbable material described hereinabove. Also the fastener portion 43 is preferably formed integrally from the same material as that of the seal portion 41 and the deformation portion 42.

Further, a lubricating surface treat member such as silicon coating is applied to the outer surface of the clip 4 formed from the bioabsorbable material to reduce the resistance of the clip 4 upon insertion into a living organism so as to facilitate arrangement of the clip 4 into a living organism. Further, if an X-ray contrast agent is mixed into a material for forming the clip 4 or coated on the surface of the clip 4, then when the clip 4 is disposed into a living organism, the position of the clip 4 can be grasped under an X-ray image.

It is to be noted that the clip 4 in the present invention is not limited to that having the configuration described above. As other configuration examples, such as those shown, for example, in (a) to (c) of FIG. 3, (a) and (b) of FIG. 4 and FIG. 5 can be listed. While description of them is given below, differences of them from the clip 4 described hereinabove with reference to FIG. 2 are described principally, and description of similar points is omitted herein.

In the clip 4 shown in (a) of FIG. 3, the pawls 431 are formed only on one side (only on the left side in (a) of FIG 3) of the fastener portion 43.

In the clip 4 shown in (b) of FIG. 3, the width of the connecting portion 44 (length in the direction perpendicular to the plane of the figure) between the seal portion 41 and the deformation portion 42 (fastener portion 43) is set narrower (shorter) than that of the clip 4 described hereinabove with reference to FIG. 2.

In the clip 4 shown in (c) of FIG. 3, the length of the fastener portion 43 in the longitudinal direction is set longer than the clip 4 described hereinabove with reference to FIG. 2, and the distal end portion of the fastener portion 43 extends through the slit 424 of the corner portion 421 of the deformation portion 42.

Further, the width of the connecting portion 44 (length in the direction perpendicular to the plane of the figure) between the seal portion 41 and the deformation portion 42 (fastener portion 43) is set narrower (shorter) than the clip 4 described hereinabove with reference to FIG. 2.

In the clip 4 shown in (a) of FIG. 4, projections 428 and 429 are formed at two corner portions 426 and 427 positioned at the diagonal positions in the leftward and rightward direction in (a) of FIG. 4, respectively. In this instance, the projection 428 extends along an extension line of a left upper link (side) in (a) of FIG. 4 which forms the deformation portion 42, and the projection 429 extends along an extension line of a right upper link (side) in (a) of FIG. 4 which forms the deformation portion 42.

When a living body tissue membrane is sandwiched between the deformation portion 42 and the seal portion 41, the subcutaneous tissues can be collected to the proximity of the wound hole by the projections 428 and 429.

Consequently, the wound hole can be closed up with a higher degree of certainty.

In the clip 4 shown in (b) of FIG. 4, the pawls 431 are formed on the opposite sides of the fastener portion 43 in the direction perpendicular to the plane of (b) of FIG. 4. In other words, the formed positions of the pawls 431 of the fastener portion 43 are displaced by a core angle of 90° with respect to the clip 4 described hereinabove with reference to FIG. 2.

Further, the width of the connecting portion 44 (length in the direction perpendicular to the plane of the figure) between the seal portion 41 and the deformation portion 42 (fastener portion 43) is set narrower (shorter) than the clip 4 described hereinabove with reference to FIG. 2.

In the clip 4 shown in FIG. 5, in its basic form (basic shape), the fastener portion 43 and the deformation portion 42 are inclined with respect to the seal portion 41.

In particular, since the body element 2 is inserted in an inclined relationship, for example, into a blood vessel by a predetermined angle with respect to the seal portion 41, the fastener portion 43 and the deformation portion 42 are inclined with respect to the seal portion 41 in a corresponding relationship. In this instance, preferably the fastener portion 43 and the deformation portion 42 are inclined with respect to the seal portion 41 to such a degree that, when the direction of the blood vessel and the direction of the major side (longitudinal direction) coincide with each other, the longitudinal direction of the body element 2 and the direction of the center axis of the fastener portion 43 substantially coincide with each other.

More particularly, the angle (inclination angle) 0 defined by the center axis of the fastener portion 43 and the surface of the seal portion 41 on the deformation portion 42 side is preferably set to a predetermined value within a range of 30 to 60°.

Thus, the wound hole can be closed with a higher degree of certainty.

It is to be noted that the shape of the deformation portion of the clip (living body tissue closure) is not limited to a quadrangular shape but may be some other polygon where it is in the shape of a framework, or may be in the shape of a framework having no angle such as an annular framework or an elliptic framework. Further, the shape of the deformation portion may be a shape different than that in the shape of a framework.

Further, in the present invention, the number of pawls at the fastener portion of the clip (living body tissue closure) may be only one.

Now, a procedure of a stanching operation (operation of the living body tissue closing device 1) performed using the living body tissue closing device 1 is described.

First, the feeding and deformation means 3 is assembled in such a manner as seen in FIG. 6.

In this instance, the stopper 12 is first mounted on the tube body 71 (position indicated by a broken line arrow mark in FIG. 1) of the pusher tube 7, and then the pusher tube 7 is inserted into the covered tube 6 from the proximal end side of the covered tube 6. Then, the stopper 12 is positioned between the hub 72 of the pusher tube 7 and the hub 62 of the covered tube 6.

Further, as shown in FIG. 1, the thread 8 is threaded into the slit 424 of the deformation portion 42 of the clip 4 from the upper side in FIG. 1 and threaded through the hole 432 of the fastener portion 43 and further threaded through slit 424 from the lower side in FIG. 1.

Further, as shown in FIG. 6, the guide wire 11 is inserted into the pusher tube 7 from the proximal end side of the pusher tube 7 and is passed through the slit 424 of the deformation portion 42 of the clip 4, the hole 425 of the deformation portion 42 and the hole 411 of the seal portion 41.

Then, the opposite end portions of the thread 8 are inserted into the pusher tube 7 from the distal end side of the pusher tube 7 and drawn out from the proximal end portion of the pusher tube 7.

Further, the deformation portion 42 of the clip 4 is deformed, and the deformed deformation portion 42 is inserted into (mounted on) the covered tube 6 from the distal end side of the covered tube 6.

Then, in this state, the thread anchoring cap 9 is mounted on the hub 72 of the pusher tube 7, and the rib 723 of the hub 72 is engaged with the groove 92 of the thread anchoring cap 9. Consequently, the opposite end portions of the thread 8 are sandwiched between the thread anchoring cap 9 and the hub 72 and retained at the proximal end portion of the pusher tube 7. The assembly of the feeding and deformation means 3 is completed thereby.

For the sheath 5, a sheath dwelling after therapy (PCI) or after treatment of a diagnosis (CAG) in which a catheter is used is used. The distal end portion of the sheath 5 is inserted in a blood vessel.

Then, the feeding and deformation means 3 is inserted into the through-hole 51 of the sheath 5 from the proximal end side of the sheath 5 as shown in FIG. 6, and the hub 62 and the hub 52 are fitted with each other and the rib 622 of the hub 62 is engaged with the groove 53 of the hub 52 as shown in FIG. 7. Consequently, the seal portion 41 of the clip 4 projects from the distal end portion of the sheath 5 and is inserted into the blood vessel.

Thereafter, the body element 2 is moved slowly in a direction in which it is pulled out from the wound hole as shown in FIG. 8 until the wound hole and a surrounding portion of the wound hole are covered from the inner side of the blood vessel wall with the seal portion 41 of the clip 4 (to perform positioning of the seal portion 41).

Consequently, the deformation portion 42 and the fastener portion 43 of the deformation portion 42 individually move to the outer side of the blood vessel. Further, the seal portion 41 having been substantially in parallel to the fastener portion 43 is guided, as it approaches the wound hole, by the guide wire 11 so that it restores in a direction in which it approaches the perpendicular direction to the fastener portion 43. Consequently, the wound hole and the surrounding portion of the wound hole can be covered readily and with certainty.

Then, the stopper 12 positioned between the hub 62 of the covered tube 6 and the hub 72 of the pusher tube 7 is removed and the covered tube 6 or the sheath 5 is moved in a direction in which it is pulled off from the wound hole until the hub 72 and the hub 62 are fitted with each other and the rib 722 of the hub 72 is engaged with the groove 623 of the hub 62 as shown in FIG. 9.

Thereafter, the thread anchoring cap 9 is removed from the hub 72 of the pusher tube 7 and the guide wire 11 is pulled off together as shown in FIG. 10. Then, while the thread 8 is pulled a little so that tension is applied to the thread 8 (while the fastener portion 43 of the clip 4 is being pulled), the body element 2 is pushed in a direction in which it is inserted into the wound hole to deform the deformation portion 42 of the clip 4 into the second form. Then, this operation is continued until after stanching is completed as shown in FIG. 11.

Consequently, the deformation portion 42 covers the wound hole and the surrounding portion of the wound hole from the outer side of the blood vessel wall while the seal portion 41 covers the wound hole and the surrounding portion of the wound hole from the inner side of the blood vessel wall. Thus, the blood vessel wall is sandwiched between the seal portion 41 and the deformation portion 42 to close the wound hole. Then, the predetermined ones of the pawls 431 of the fastener portion 43 engage with the corner portion 421 of the deformation portion 42 to retain the deformation portion 42 in the second form.

Finally, the body element 2 and the thread 8 are pulled off while the clip 4 is disposed (dwells) in the living organism. The stanching operation is completed thereby.

As described above, according to the present living body tissue closing device 1, the safety is high, and a stanching operation can be performed readily and with certainty for a wound hole formed in a living body tissue membrane such as a blood vessel wall. In other words, the wound hole can be closed (sealed) readily and with certainty, and the bleeding can be stanched completely.

<Second Embodiment> Now, a second embodiment of a living body tissue closing device of the present invention is described.

FIG. 13 is a perspective view showing the second embodiment of the living body tissue closing device of the present invention; FIG. 14 is a perspective view showing a living body tissue closure of the living body tissue closing device shown in FIG. 13; FIG. 15 is a perspective view showing another example of a configuration of the living body tissue closure of the living body tissue closing device shown in FIG. 13 ; and FIGS. 16 and 17 are sectional views illustrating action (operation) of the living body tissue closing device shown in FIG. 13.

It is to be noted that, in FIG. 14, a pusher tube 7 is schematically shown by a broken line.

Further, for the convenience of description, in FIGS. 13,16 and 17, the left lower side is referred to as "distal end"and the right upper side (hand side) is referred to as"proximal end". Further, in FIGS. 14 and 15, although the upper side of the living body tissue closing device as a whole is the"proximal end"and the lower side is the"distal end", as regards a clip (living body tissue closure) 4, the upper side in the figures is referred to as"distal end"and the lower side is referred to as"proximal end".

In the following description, the living body tissue closing device 1 of the second embodiment is described principally in connection with differences thereof from the first embodiment described hereinabove, and description of similar matters is omitted herein.

As shown in FIGS. 13 and 14, the living body tissue closing device 1 of the second embodiments omits the guide wire 11.

Further, the clip (living body tissue closure) 4 includes a seal portion 41, a deformable deformation portion (retaining portion) 42 adjacent the seal portion 41, a fastener portion 43 for retaining, when the deformation portion 42 enters a state of a predetermined form between a contracted form and an expanded form, the deformation portion 42 in the state, and a connecting portion 44 for connecting the seal portion 41 and the deformation portion 42 to each other. The seal portion 41, deformation portion 42, fastener portion 43 and connecting portion 44 are preferably formed integrally from the same material.

The seal portion 41 is a member having a flat face portion (flat face) for closely contacting with a surrounding portion of a wound hole (portion including the wound hole) of a living body tissue membrane from one side (inner surface) of the living body tissue membrane to cover the wound hole and the surrounding portion of the wound hole, and has a shape of a plate.

The face (upper side face in FIG. 14) of the seal portion 41 to which the deformation portion 42 hereinafter described is connected is a substantially flat face.

The deformation portion 42 has a shape like a pantograph and is connected (coupled) to a substantially middle portion of the seal portion 41 through a connecting portion 44.

In particular, the deformation portion 42 has a shape of a framework which can be deformed between a contracted form in which it extends in a direction substantially perpendicular to the seal portion 41 (reference plane: for example, the surface of the seal portion 41 on the deformation portion 42 side) and is contracted in a substantially parallel direction to the seal portion 41 and an expanded form in which it extends in a direction substantially perpendicular to the seal portion 41 and is expanded in a direction substantially in parallel to the seal portion 41. Accordingly, the deformation portion 42 can be deformed from the basic form (basic shape) shown in (b) of FIG. 14 to an arbitrary form between the contracted form and the expanded form described above such as a first form shown in (a) of FIG.

14 wherein it can pass through a wound hole and a second form shown in (c) and (d) of FIG. 14 wherein the deformation portion 42 cooperates with the seal portion 41 to sandwich the living body tissue membrane therebetween from the other side (outer surface) of the living body tissue membrane. The deformation portion 42 cooperates with the seal portion 41 to sandwich the living body tissue membrane therebetween from the other side to retain (hold) the seal portion 41 to the one side of the living body tissue membrane. Accordingly, the deformation portion 42 forms retainer for cooperating with the seal portion 41 to sandwich a living body tissue membrane from the other side of the living body tissue membrane to retain the seal portion to the one side.

Here, in the present embodiment, the deformation portion 42 has a quadrangular annular shape by bending a. belt-like member four times (shape having a polygonal annular shape by bending a belt-like member by a plural number of times). In particular, the deformation portion 42 includes four links formed integrally with each other and has a quadrangular shape (shape of a quadrangular framework) having four corners which can be bent like a hinge. Then, from between the two corner portions 421 and 422 positioned at diagonal positions in the upward and downward direction in FIG. 14, the corner portion 422 on the lower side (seal portion 41 side) in FIG. 14 is connected to a substantially middle portion of the seal portion 41 through the connecting portion 44 and thus serves as a fixed portion which cannot move with respect to the upper side end portion of the connecting portion 44 in FIG. 14 or the fastener portion 43.

Consequently, the deformation portion 42 is deformed such that the corner portion 421 and the corner portion 422 move toward and away from each other. In particular, the deformation portion 42 can be deformed into expanded and contracted states in two directions perpendicular to each other and can rock (turn around an axis of turning motion) with respect to the seal portion 41. In this instance, the a connecting portion between the seal portion 41 and the corner portion 422 of the deformation portion 42, that is, the connecting portion 44, has flexibility (elasticity), and the seal portion 41 is turned as the connecting portion 44 is bent (resiliently deformed).

Further, the upper face of the corner portion 421 (surface on the opposite side to the seal portion 41) on the upper side (on the opposite side to the seal portion 41) in FIG. 14 from between the two corner portions 421 and 422 is formed as a curved convex face. A substantially H-shaped slit 424 is formed in the corner portion 421 as shown in FIG. 14. The slit 424 is an opening extending through the deformation portion 42 in the shape of a framework, and at least part of the fastener portion 43 can be inserted (fitted) into the slit 424 (the fastener portion 43 can be accepted).

Further, on the outer side of the deformation portion 42 on the seal portion 41 side, that is, in the proximity of the corner portion 422, a pair of projections 46 are provided which project toward the seal portion 41 side. Each of the projections 46 extends in a widthwise direction of the deformation portion 42, and a portion thereof on the seal portion 41 side has a pointed end.

The length of the deformation portion 42 of each of the projections 46 in the widthwise direction of the deformation portion 42 is set substantially equal to the width of the deformation portion 42.

Consequently, the projections 46 are positioned in the proximity of the wound hole closed with the living body tissue closure 4, and the wound hole is tightened strongly by the projections 46. Consequently, the bleeding can be stanched with a higher degree of certainty.

Further, even if failure in stanching (for example, when the blood vessel wall or the subcutaneous tissue is so hard that the deformation portion 42 cannot be expanded or the like) occurs and manual astriction becomes required and force in the direction in which the living body tissue closure 4 is inserted transcutaneously into the blood vessel is applied to the living body tissue closure 4 by the manual astriction, a drop (omission) of the living body tissue closure 4 into the blood vessel can be prevented by the projections 46. This enhances the safety.

The connecting portion 44 has a shape of a plate.

The seal portion 41 and the corner portion 422 of the deformation portion 42 can be spaced away from each other by a predetermined distance by the connecting portion 44.

The fastener portion 43 has a shape of a plate.

The fastener portion 43 is positioned within the framework of the deformation portion 42 and connected at the proximal end portion thereof (lower side end portion in FIG. 14) to the inner surface of the deformation portion 42 (connected to the seal portion 41 through the corner portion 422 and the connecting portion 44).

Consequently, the fastener portion 43 can rock (turn around one axis of turning motion) together with the deformation portion 42 with respect to the seal portion 41.

In other words, the seal portion 41 can rock (turn around one axis of turning motion) with respect to the deformation portion 42 and the fastener portion 43.

The pawls 431 are formed on one side (right side) of the fastener portion 43 in the leftward and rightward direction in FIG. 14. A plurality of (two in the example shown in the figure) such pawls 431 are juxtaposed in a spaced relationship by a predetermined distance from each other along the longitudinal direction (upward and downward direction in FIG. 14) of the fastener portion 43.

It is to be noted that the configuration of the projections 46 of the deformation portion 42 of the clip 4 in terms of the shape, position and number is not limited to that described above. As another example of a configuration, for example, a configuration shown in FIG.

15 is listed. In the clip 4 shown in FIG. 15, each of the projections 46 has, as viewed in plan (as viewed from the upper side in FIG. 15), a substantially triangular shape which is pointed toward a central portion of the deformation portion 42 in the widthwise direction.

Here, as shown in FIGS. 14 and 16, the seal portion 41 of the clip 4 is preferably set such that the length L (length in the longitudinal direction) of the longest portion thereof is smaller than the inner diameter (diameter) R of a portion of a living organism lumen (for example, a blood vessel) (inserted portion) in which the clip 4 is inserted. More particularly, the length of the longest portion of the seal portion 41 preferably is equal to or less than 6 mm, more preferably equal to or less than 5 mm, and is further preferably approximately 3.5 to 4.5 mm.

Consequently, the seal portion 41 of the clip 4 is permitted to turn (displace) freely with respect to the deformation portion 42, and for example, such advantages are achieved.

As shown in FIG. 16, where a blood vessel is branched intermediately on the distal end side with respect to a wound hole in the blood vessel wall, the seal portion 41 of the clip 4 sometimes interferes with the branched portion of the blood vessel halfway of an operation of moving the body element 2 in a direction in which it is pulled out from the wound hole and covering the wound hole and a surrounding portion around the wound hole from the inner side of the blood vessel wall with the seal portion 41 of the clip 4 (positioning of the seal portion 41).

At this time, as shown in FIG. 17, the seal portion 41 can turn with respect to the deformation portion 42 and be brought off interference with the branched portion of the blood vessel. Consequently, the seal portion 41 can be prevented from being caught by the branched portion of the blood vessel.

Further, since the seal portion 41 can turn (bent only in a fixed direction) around one axis of turning motion with respect to the deformation portion 42, the seal portion 41 can be moved readily and stably along the route of the blood vessel, and finally, the seal portion 41 can be positioned at an optimum position with respect to the wound hole of the blood vessel wall (can be positioned such that the longitudinal direction thereof has a substantially parallel positional relationship to the route of the blood vessel. Consequently, the bleeding can be stanched with a higher degree of certainty.

Further, since positioning of the seal portion 41 can be performed only by inserting the living body tissue closure 4 once into the deepest portion of the blood vessel on the central side and then moving the body element 2 in a direction in which it is pulled off from the wound hole, the stanching operation can be performed very readily and with certainty.

With the living body tissue closing device 1, similar effects to those of the living body tissue closing device 1 of the first embodiment described hereinabove can be achieved.

<Third Embodiment> Now, a third embodiment of a living body tissue closing device of the present invention is described.

FIG. 18 is a perspective view showing a third embodiment of a living body tissue closing device of the present invention; and FIGS. 19 and 20 are perspective views illustrating action (operation) of the living body. tissue closing device shown in FIG. 18.

It is to be noted that, in FIGS. 18 to 20, the proximal end side of each of the covered tube 6 and the pusher tube 7 is not shown.

Further, for the convenience of description, in FIGS. 18 to 20, the left lower side is referred to as "distal end"and the right upper side (hand side) is referred to as"proximal end". However, as regards a clip (living body tissue closure) 4, the upper side in the figures is referred to as"distal end"and the lower side is referred to as"proximal end".

In the following description, the living body tissue closing device 1 of the third embodiment is described principally in connection with differences thereof from the second embodiment described hereinabove, and description of similar matters is omitted herein.

As shown in FIG. 18, the living body tissue closing device 1 includes a thread (string member) 13 serving as deformation portion pulling means for pulling the deformation portion 42 of the clip 4 to the proximal end side of the feeding and deformation means (arrangement device) 3.

In a state wherein the thread 13 is threaded through the deformation portion 42 and suspended on the corner portion 421, the opposite end portions thereof are drawn out from the proximal end side of the covered tube 6 and the pusher tube 7 to the outside. The thread 13 forms retainer for retaining (accommodating) the deformation portion 42 of the clip 4 at the distal end portion of the covered tube 6 (on the distal end side of the feeding and deformation means 3).

Further, the covered tube 6 has a contacting portion 63 provided at the distal end portion of the tube body 61.

The contacting portion 63 has a shape of a plate which projects in the direction of the distal end from the distal end of the tube body 61, that is, such a shape that part of a wall portion which forms the tube body 61 is extended to the direction of the distal end thereof.

In this instance, the contacting portion 63 is preferably formed such that it satisfies a relationship of a > L where a is the length of the covered tube 6 in the longitudinal direction and L is the length (length in the longitudinal direction) of the longest portion of the deformation portion 42.

The contacting portion 63 forms displacement means for displacing the seal portion 42 of the clip 4 so that it may extend substantially in parallel to the longitudinal direction (axial direction) of the feeding and deformation means (arrangement device) 3.

With the living body tissue closing device 1, the clip 4 inserted in a blood vessel (living organism lumen) can be recovered from within the blood vessel halfway of a stanching operation.

Now, a procedure (operation of the living body tissue closing device 1) when the clip 4 in a state wherein the seal portion 41 of the clip 4 is positioned within a blood vessel while the deformation portion 42 and the fastener portion 43 are positioned outside the blood vessel as shown in FIG. 18 is described.

First, the thread 13 is pulled to the proximal end side of the feeding and deformation means 3 (to pull the deformation portion 42 of the clip 4 to the proximal end side) to deform the deformation portion 42 so that the deformation portion 42 is expanded in a direction substantially perpendicular to the seal portion 41 and contracted in a direction substantially in parallel to the seal portion 41 (so as to be closed) as shown in (a) of FIG. 19.

Then, while the thread 13 is pulled to the proximal end side of the feeding and deformation means 3 (to pull the deformation portion 42 of the clip 4 to the proximal end side), the covered tube 6 is pushed out (advanced) in the direction of the distal end until the deformation portion 42 is retained (accommodated) in the proximal end portion of the covered tube 6 as shown in (b) of FIG. 19.

Then, the feeding and deformation means 3 is moved in the direction of the distal end thereof so that the proximal end portion of the covered tube 6 into a blood vessel until the seal portion 41 is positioned to a position at which the seal portion 41 of the clip 4 can turn (to move the seal portion 41 away from the inner surface of the blood vessel wall in which the wound hole is formed) as shown in (c) of FIG. 19.

Thereafter, while the thread 13 is being pulled to the proximal end side of the feeding and deformation means 3 (while the deformation portion 42 of the clip 4 is being pulled to the proximal end side), the covered tube 6 is pushed out (propelled) in the direction of the distal end as shown in (d) of FIG. 20. Consequently, the face of the seal portion 41 on the deformation portion 42 side contacts with the contacting portion 63 and the seal portion 41 turns (displaces) with respect to the deformation portion 42 until it comes to a position in which it extends substantially in parallel to the longitudinal direction (axial direction) of the covered tube 6 (feeding and deformation means 3).

Then, the covered tube 6 is turned by approximately 180° so that the upper side end portion of the seal portion 41 in (e) of FIG. 20 can be pulled off readily from the wound hole or the wound of the blood vessel as shown in (e) of FIG. 20.

Finally, the feeding and deformation means 3 and the clip 4 are pulled off from the wound hole or wound of the blood vessel as shown in (f) of FIG. 20. By the procedure described above, the clip 4 is recovered from within the blood vessel. Thereafter, predetermined treatment such as manual astriction is performed.

With the living body tissue closing device 1, similar effects to those of the living body tissue closing device 1 of the second embodiment described hereinabove are achieved.

Further, even if the deformation portion 42 of the clip 4 does not open (for example, when the blood vessel is hard due to calcification, when the subcutaneous tissue has a hard trace by re-punctures or the like) and failure in stanching of the bleeding occurs, with the living body tissue closing device 1, the clip 4 inserted in the blood vessel can be recovered readily and with certainty from within the blood vessel, and thereafter, for example, ordinary manual astriction can be preformed. Consequently, the safety is enhanced significantly.

While the living body tissue closure and the living body tissue closing device of the present invention are described above with reference to the embodiments shown in the drawings, the present invention is not limited to them, but the configuration of the components can be replaced by an arbitrary configuration having similar functions.

Further, the present invention may have any other component added thereto.

Further, the present invention may include a combination of two or more arbitrary ones of configurations (features) from within the embodiments described hereinabove.

Further, according to the present invention, the seal portion 41 may have such a structure (configuration) as that of the deformation portion 42 described hereinabove.

Further, according to the present invention, the fastener portion 43 may be such a filament that passes through from inner side of the deformation portion 42 to the corner portion 421. The filament may fix the deformation portion 42 by its knot on the upper side of the corner portion 421.

Industrial Applicability According to the present invention, stanching operation for a wound hole formed in a living body tissue membrane such as a blood vessel wall can be performed readily with certainty and with a high degree of safety.

In other words, the wound hole can be closed (closed up) readily and with certainty, and the blooding can be stanched completely.

Accordingly, the present invention has industrial applicability.