JP4589643B2 - In vivo tissue closure device - Google Patents

Description

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

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

  Such insertion of a catheter into a blood vessel is usually performed through a puncture hole formed 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, an in-vivo tissue closing device is known that does not use a suture thread (see, for example, Patent Document 2).

  In this in-vivo tissue closing device, a seal portion installed at the distal end portion of the device main body is inserted into the blood vessel via a tube that has already been inserted into the blood vessel. The seal portion inserted into the blood vessel is expanded to a state expanded from the device main body (scratch hole) by its own elastic force (restoring force) and rotation, and the device main body is pulled while maintaining this state. Thus, hemostasis is performed by sealing the wound hole and the surrounding blood vessel inner wall with the seal portion. In the in-vivo tissue closing device having such a configuration, the process of expanding the seal portion in the blood vessel is very important for positioning the seal portion with respect to the subsequent wound and sealing.

  However, in the in-vivo tissue closing device, since it is not possible to confirm that the seal portion is deployed during the hemostasis operation, pulling out of the blood vessel due to poor deployment of the seal portion or poor hemostasis occurs. There is.

Japanese National Patent Publication No. 8-504618 US Pat. No. 5,690,674

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

Such an object is achieved by the present invention of the following (1) to ( 23 ).
(1) An in-vivo tissue closing device for closing a wound penetrating an in-vivo tissue membrane,
An elongate main body that allows the tip to penetrate the wound,
Removably attached to the distal end portion of the main body portion, and capable of penetrating the wound hole together with the distal end portion of the main body portion, comprising a closing means for closing the wound hole,
The closing means includes a seal part that covers the wound hole and a peripheral part of the wound hole from one surface side of the in-vivo tissue film, and a fixing part that fixes the seal part to the in-vivo tissue film. The seal part is developed in a form that can cover the wound hole and the peripheral part of the wound hole in a state where the seal part is attached to the tip of the main body part and penetrates the wound hole. Yes,
The main body has an inflow opening that opens when the closing means is deployed, and includes a lumen that guides body fluid flowing from the inflow opening, and the closing means is attached to the distal end of the main body. And an in-vivo tissue closing device comprising detecting means for detecting that the wound has been deployed through the wound.

(2) A biological tissue closing device for closing a wound penetrating a biological tissue membrane,
An elongate main body that allows the tip to penetrate the wound,
Removably attached to the distal end portion of the main body portion, and capable of penetrating the wound hole together with the distal end portion of the main body portion, comprising a closing means for closing the wound hole,
The closing means includes the seal portion covering the wound hole and a peripheral portion of the wound hole from one surface side of the in vivo tissue membrane, and the seal portion from the other surface side of the in vivo tissue membrane. A fixing part for fixing the seal part to the in vivo tissue membrane by sandwiching the body tissue membrane, and attached to the distal end portion of the main body part and penetrating the wound, The seal part is developed in a form capable of covering the wound hole and the peripheral part of the wound hole,
The main body has an inflow opening that opens when the closing means is deployed, and includes a lumen that guides body fluid flowing from the inflow opening, and the closing means is attached to the distal end of the main body. And an in-vivo tissue closing device comprising detecting means for detecting that the wound has been deployed through the wound.

(3) The in-vivo tissue closing device according to (1) or (2), wherein the in-vivo tissue membrane is a blood vessel wall, and the one surface is an inner surface of the blood vessel wall .

(4) The in vivo tissue closing device according to any one of (1) to (3) , wherein the inflow port is closed by the seal portion before the closing means is deployed.

  (5) The in-vivo tissue closing device according to any one of (1) to (4), wherein the main body portion includes a holding unit that detachably holds the closing unit.

  (6) The in vivo tissue closing device according to (5), wherein the holding means holds at least the fixing portion of the closing means.

  (7) The fixing portion of the closing means is a direction in which the main body portion is pulled out from the wound hole with respect to the closing means in a state where the seal portion is deployed and is in contact with one surface of the in vivo tissue membrane. (6) configured to be deployed so as to be released from the holding means and detached from the distal end portion of the main body portion and to fix the seal portion to the tissue tissue in the living body. The in-vivo tissue closure device described in 1.

  (8) The said closing means has a recessed part with which the said holding means fits, and the said holding means fits into this recessed part, and is attached to the front-end | tip part of the said main-body part so that attachment or detachment is possible (5). Or the in-vivo tissue closure apparatus as described in (6).

(9) The holding means includes a long first holding member and a long second holding member,
The closing means has a recess into which the first holding member is fitted, and the first holding member is fitted into the recess, and the fixing portion is held by the second holding member. The in-vivo tissue closure device according to (5) or (6), wherein the device is configured to be detachably attached to the distal end of the main body.

  (10) The fixing portion of the closing means may be configured such that the second holding member is in contact with the closing means in a state where the seal portion is deployed and is in contact with one surface of the in vivo tissue membrane. The living body according to (9), which is configured to be deployed so as to be released from the second holding member and fixed to the tissue membrane in the living body by being moved in a direction to be removed from the living body tissue. Body tissue closure device.

  (11) The closing means is in a direction in which the first holding member is pulled out from the wound hole with respect to the closing means in a state where the seal portion is deployed and is in contact with one surface of the tissue tissue in vivo. The in-vivo tissue closing device according to (10), wherein the in-vivo tissue closing device is released from the first holding member and detached from the distal end portion of the main body portion by being moved.

  (12) The second holding member includes a cylindrical portion having a substantially cylindrical shape, and the first holding member is inserted into the cylindrical portion according to any one of (9) to (11). The in-vivo tissue closure device described.

  (13) Said (9) thru | or (12) comprised so that the said 2nd holding member can move relatively along the longitudinal direction of this 2nd holding member with respect to a said 1st holding member. ) In vivo tissue closing device.

  (14) The in vivo tissue closing device according to any one of (1) to (13), wherein the seal portion and the fixing portion are each elastically deformable.

  (15) The in-vivo tissue closure device according to (14), wherein the seal portion and the fixing portion are each in a natural state, have a plate shape, and face each other.

  (16) The in vivo tissue closure device according to any one of (1) to (15), wherein the seal portion and the fixing portion are integrally formed.

  (17) The holding means has a thread-like member, the fixing part of the closing means is held on one end side of the thread-like member, and the other end side of the thread-like member is held on the base end side of the main body part. The in-vivo tissue closing device according to (5) or (6) configured as described above.

  (18) The fixing portion of the closing means is released from the thread-like member, and the sealing portion is deployed to be in contact with one surface of the in-vivo tissue membrane, and the main body portion is closed with the closing means. By moving in the direction in which it is removed from the wound hole, it is released from the holding means and detached from the distal end portion of the main body portion so as to be deployed so as to fix the seal portion to the tissue tissue in vivo. The in-vivo tissue closing device according to (17), which is configured.

  (19) The in vivo tissue closure device according to any one of (1) to (7), (17), and (18), wherein the fixing portion is elastically deformable.

  (20) The in-vivo tissue closure device according to any one of (1) to (7) and (17) to (19), wherein the fixing portion has a substantially annular shape.

  (21) The in-vivo tissue closing device according to any one of (1) to (7), (17) to (20), wherein the fixing portion is provided so as to be swingable with respect to the seal portion.

  (22) The in-vivo tissue closing device according to any one of (1) to (7) and (17) to (21), wherein the seal portion has a plate shape.

  (23) The in-vivo tissue closing device according to any one of (1) to (22), wherein at least a part of the closing means is made of a bioabsorbable material.

  According to the present invention, since the detecting means for detecting that the closing means has been deployed is provided, it is confirmed that the closing means has been deployed during the hemostasis operation for the wound formed in the in vivo tissue membrane. Thus, the hemostasis work can be performed easily and reliably (there is no need to repeat the hemostasis work many times). That is, the wound can be easily and reliably closed (closed), and can be completely hemostatic.

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

  1 is a cross-sectional view showing a first embodiment of the in-vivo tissue closing device of the present invention, FIG. 2 is a perspective view showing a closing means of the in-vivo tissue closing device shown in FIG. 1, and FIGS. FIG. 2 is a cross-sectional view for explaining the action (operation) of the biological tissue suturing apparatus shown in FIG.

  In this case, FIG. 2 shows the shape of the clip (closing means) 4 in a natural state where no external force is applied (when not attached). FIG. 5 shows only half of the sheath and the second holding member.

  For convenience of explanation, in FIGS. 1 and 3 to 5, the lower left side in the drawing is described as “tip”, and the upper right side (hand side) is described as “base end”.

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

  As shown in FIGS. 1 and 2, the in-vivo tissue closing device 1 includes an elongated main body 2 and a wound hole that is detachably attached to the distal end of the main body 2 and penetrates the in-vivo tissue membrane. A clip (plug) 4 as a closing means for closing is provided. This in-vivo tissue closure device 1 has a detecting means (in this embodiment, a lumen 74) for detecting that the clip 4 is deployed in a state where the clip 4 is attached to the distal end portion of the main body 2 and penetrates the wound hole. Have. Hereinafter, each of these components will be sequentially described.

  The main body 2 includes a sheath 5 having a through hole 51 penetrating in the axial direction at the center, and a long closure (holding means) 3 that is detachably attached to the sheath 5. The closure 3 serves as both a holding unit that detachably holds the clip 4 and a transfer unit that transfers the clip 4. During the hemostasis operation (operation for closing the wound hole), the sheath 5 and the distal end portion of the closure 3 and the clip 4 respectively penetrate the wound hole. That is, it is inserted into a living body lumen (biological lumen) such as a blood vessel from a wound hole.

  The sheath 5 has a substantially cylindrical shape and has a hub 52 at the base end thereof. A groove 53 is formed on the outer peripheral surface of the hub 52 along the circumferential direction.

  As the sheath 5, for example, a sheath (introducer sheath) placed after treatment using a catheter (PCI) or diagnosis (CAG) may be used. It may be. That is, the sheath 5 may or may not be included in the constituent elements of the main body 2.

  The closure 3 has a long first holding member (bar-shaped member) 6 and a long second holding member (tubular member) 7.

  The first holding member 6 includes a substantially columnar (rod-like) main body 61, a holding part 62 provided at the distal end of the main body 61, and a flange (gripping part) 63 provided at the base end of the main body 61. It is configured. The clip 4 is detachably attached to the holding portion 62 of the first holding member 6.

Ribs 611 are formed on the outer peripheral surface of the base end side of the main body 61 along the circumferential direction.
The holding portion 62 has a small-diameter portion 621 having a smaller outer diameter than the main body 61 and has a substantially T shape. The outer diameter of the front end portion (fitting portion) 622 of the holding portion 62 is set larger than the outer diameter of the small diameter portion 621 and smaller than the outer diameter of the main body 61.

  The second holding member 7 includes a main body (tubular portion) 71 having a substantially cylindrical shape (tubular shape), and a hub 72 provided at a base end portion of the main body 71. The clip 4 is detachably attached to the distal end portion of the second holding member 7. Further, the first holding member 6 is inserted into the second holding member 7.

  A thread groove 73 into which a rib 611 formed on the main body 61 of the first holding member 6 can be screwed is formed on the inner peripheral surface on the proximal end side of the main body 71.

  The hub 72 has a cylindrical tubular portion 721. Ribs 722 that can be engaged with the grooves 53 formed in the hub 52 of the sheath 5 are formed along the circumferential direction on the inner peripheral surface of the cylindrical portion 721.

  The second holding member 7 is provided with a backflush lumen (detecting means) 74 having an inflow port 741 at the tip thereof and an outflow port 742 on the outer peripheral surface of the hub 72.

  The inlet 741 of the lumen 74 is closed (closed) by the seal portion 41 before the later-described clip 4 (the seal portion 41 of the clip 4) is deployed. The lumen 74 opens (opens) the inlet 741 when the clip 4 (the seal portion 41 of the clip 4) is deployed, and guides blood (body fluid) flowing from the inlet 741 to the outlet 742. Is possible.

  The inner diameter of the cylindrical portion 721 of the hub 72 is slightly larger than the outer diameter of the hub 52 of the sheath 5, and the outer diameter of the main body 71 is slightly smaller than the inner diameter of the sheath 5. Thereby, the main body 71 of the second holding member 7 can be inserted into the sheath 5, and the hub 52 of the sheath 5 is inserted into the cylindrical portion 721 of the hub 72 of the second holding member 7. The rib 722 of the hub 72 can be engaged with the groove 53 of the hub 52. By engaging the rib 722 with the groove 53, the other of the sheath 5 and the second holding member 7 is prevented from being detached and the operation becomes easy.

  The inner diameter of the main body 71 is slightly larger than the outer diameter of the main body 61 of the first holding member 6. Thereby, the main body 61 of the first holding member 6 can be inserted into the main body 71 of the second holding member. In this case, the rib 611 of the first holding member 6 is screwed (engaged) with the thread groove 73 of the second holding member 7, so that one of the first holding member 6 and the second holding member 7 is the other. Is prevented from being detached, and the positional relationship between the first holding member 6 and the second holding member 7 can be held constant, which is easy to operate.

  When the second holding member 7 is rotated in a predetermined direction with respect to the first holding member 6, the second holding member 7 is moved relative to the first holding member 6 by the action of the rib 611 and the screw groove 73. The second holding member 7 (first holding member 6) moves to the proximal side along the longitudinal direction. Further, when the second holding member 7 is rotated in the opposite direction to the first holding member 6, the second holding member 7 moves to the tip side with respect to the first holding member 6. The same applies to the case where the first holding member 6 is rotated with respect to the second holding member 7.

  Further, as shown in FIG. 3, the position of the tip of the second holding member 7 and the sheath in a state where the closure 3 is mounted on the sheath 5 (a state where the rib 722 of the hub 72 is engaged with the groove 53 of the hub 52). The position of the tip of 5 substantially matches. Further, the distal end of the second holding member 7 may be positioned closer to the distal end side than the distal end of the sheath 5 with the closure 3 attached to the sheath 5. Thereby, when the closure 3 is attached to the sheath 5, a seal portion 41 of the later-described clip 4 attached to the distal end portion of the closure 3 can be developed.

  As shown in FIGS. 1, 2, and 6, the clip (closing means) 4 includes a seal portion 41, and a fixing portion (support portion) 42 that fixes (holds) the seal portion 41 to the tissue tissue in vivo. The connecting portion 43 connects the sealing portion 41 and the fixing portion 42. Each of the seal portion 41, the fixed portion 42, and the connecting portion 43 can be elastically deformed and is integrally formed of the same material.

  In addition, you may form any one or all of the seal part 41, the fixing | fixed part 42, and the connection part 43 with another member.

  The seal portion 41 is a member having a flat surface portion 411 that covers a wound hole and a peripheral portion of the wound hole (a portion including the wound hole of the biological tissue film) from one surface (inner surface) side of the biological tissue film. It has a shape. In the illustrated example, the seal portion 41 has a substantially track shape (a shape in which both sides are a circle and a center is a rectangle) or a substantially oval shape in a plan view in a natural state where no external force is applied as shown in FIG.

  The fixing portion 42 has a function of fixing (holding) the seal portion 41 to the in vivo tissue membrane by sandwiching the in vivo tissue membrane with the seal portion 41 from the other surface (outer surface) side of the in vivo tissue membrane. It has a plate shape. In the illustrated example, the fixed portion 42 has a shape substantially the same as the seal portion 41 in a plan view in a natural state where no external force is applied as shown in FIG. 2, that is, a substantially track shape (a shape in which both sides are a circle and a center is a rectangle). Or it has a substantially elliptical shape. In this case, the length of the fixing portion 42 in the longitudinal direction is set longer than the length of the sealing portion 41 in the longitudinal direction.

  When the in-vivo tissue membrane is a blood vessel wall (biological lumen wall), the one surface is an inner surface of the blood vessel wall (biological lumen wall), and the other surface is a blood vessel wall (biological lumen). Wall).

  The seal portion 41 and the fixed portion 42 face each other and are separated by a predetermined distance in a natural state where no external force is applied as shown in FIG.

  The connecting portion 43 is disposed in the central portion of the seal portion 41 (fixed portion 42), and the seal portion 41 and the fixed portion 42 are connected to each other via the connecting portion 43 at the central portion. . The length of the connecting portion 43 in the longitudinal direction of the seal portion 41 (fixed portion 42) is set sufficiently shorter than the length of the seal portion 41 (fixed portion 42) in the longitudinal direction. Further, the length (width) of the connecting portion 43 in the direction perpendicular to the longitudinal direction of the seal portion 41 (fixed portion 42) and parallel to the flat surface portion 411 is equal to that of the seal portion 41 (fixed portion 42). It is set shorter than the length in that direction.

  The clip 4 is provided with a recess 44 into which the front end 622 of the holding portion 62 of the first holding member 6 is fitted. The concave portion 44 is opened (opened) to the upper surface in FIG. 2 at the center of the fixing portion 42, and is formed from the upper surface in FIG. 2 to the connecting portion 43.

  A lower portion (front end side) portion 441 of the concave portion 44 in FIG. 2 is a portion into which the front end portion 622 of the holding portion 62 of the first holding member 6 is fitted. This corresponds to the shape and size of the tip 622. The lower portion 441 of the concave portion 44 has a direction perpendicular to the longitudinal direction of the seal portion 41 (fixed portion 42) and parallel to the surface of the flat portion 411 as the longitudinal direction. Further, the upper portion (base end side) portion 442 of the concave portion 44 in FIG. 2 can fit the distal end portion 622 of the holding portion 62 of the first holding member 6 into the lower portion 441 of the concave portion 44. And it is formed smaller than the lower part 441 so that the front-end | tip part 622 of the holding | maintenance part 62 fitted to the lower part 441 can be disengaged. Accordingly, the clip 4 can be reliably held by the holding portion 62 of the first holding member 6 and can be detached from the holding portion 62 when necessary.

  As shown in FIG. 1, the clip 4 is connected to the lower portion 441 of the recess 44 by the distal end portion 622 of the holding portion 62 of the first holding member 6 and the fixing portion 42 is elastically deformed. 43 (recessed portion 44) is symmetrically bent toward the proximal end side, and both end portions in the longitudinal direction of the fixing portion 42 are respectively held by the distal end portion of the second holding member 7, The closure 3 (main body 2) is detachably attached to the tip.

  Further, when the clip 4 is inserted into the through hole 51 of the sheath 5 together with the closure 3, the seal portion 41 is elastically deformed and bent symmetrically about the connecting portion 43 (concave portion 44) to the proximal end side. In a state before the seal portion 41 of the clip 4 is deployed, one end portion in the longitudinal direction of the seal portion 41 abuts (pressure contact) with a region including the inlet 741 of the lumen 74 in the second holding member 7. The inlet 741 is closed (closed). Thereby, the inflow of blood (body fluid) from the inflow port 741 to the lumen 74 is prevented.

  Examples of the constituent material of the clip 4 include various rubbers and various thermoplastic elastomers. In particular, it is preferable that the entire clip 4 is integrally formed of a bioabsorbable material. By using the bioabsorbable material, the clip 4 is absorbed by the living body after a predetermined period and finally does not remain in the living body, so that the influence on the human body can be eliminated.

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

  In the present invention, it goes without saying that the clip 4 is not limited to the one having the above-described configuration.

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

  First, as shown in FIG. 1, the closure 3 is assembled, and the clip 4 is attached to the tip of the closure 3.

  In this case, first, the first holding member 6 is inserted into the second holding member 7 from the base end side of the second holding member 7, and the rib 611 of the first holding member 6 is inserted into the second holding member 7. The first holding member 6 is rotated in a predetermined direction with respect to the second holding member 7. As a result, the first holding member 6 moves to the proximal end side with respect to the second holding member 7, so that the first holding member 6 is moved by a predetermined length from the distal end portion of the second holding member 7. Only protrude.

  Then, the front end portion 622 of the holding portion 62 of the first holding member 6 is fitted into the lower portion 441 of the concave portion 44 of the clip 4. Further, the fixing portion 42 of the clip 4 is elastically deformed and bent symmetrically around the connecting portion 43, and both end portions in the longitudinal direction of the fixing portion 42 are respectively connected to the distal end portion of the second holding member 7. Insert and hold. As a result, the clip 4 is detachably attached to the tip of the closure 3.

  As the sheath 5, a sheath placed after treatment (PCI) or diagnosis (CAG) using a catheter is used. The distal end portion of the sheath 5 is inserted into the blood vessel.

  Next, as shown in FIG. 1, the clip 4 together with the closure 3 is inserted into the through hole 51 of the sheath 5 from the proximal end side of the sheath 5. At this time, the seal portion 41 of the clip 4 is elastically deformed and is bent toward the proximal end symmetrically with the connecting portion 43 as the center. At this time, the second holding member 7 is arranged such that one end portion in the longitudinal direction of the seal portion 41 comes into contact (pressure contact) with a region including the inlet 741 of the lumen 74 in the second holding member 7. On the other hand, the first holding member 6 is rotated in a predetermined direction to adjust the position of the first holding member 6 with respect to the second holding member 7. As a result, the inlet 741 is closed (closed) by the seal portion 41.

  Then, the closure 3 is further inserted into the through hole 51 of the sheath 5, and the hub 72 and the hub 52 are fitted to each other as shown in FIG. 3, and the rib 722 of the hub 72 is engaged with the groove 53 of the hub 52. Let Thereby, substantially the whole clip 4 including the seal portion 41 protrudes from the distal end portion of the sheath 5, and the clip 4 penetrates the wound hole and is inserted into the blood vessel. At this time, the seal portion 41 of the clip 4 is released from the distal end portion of the sheath 5 and restored to its original shape before being inserted into the through hole 51 of the sheath 5 by its own elastic force (restoring force). That is, the seal portion 41 of the clip 4 expands (opens) into a form in which the seal portion 41 can cover the wound hole and the peripheral portion of the wound hole from the inside of the blood vessel wall.

  When the seal portion 41 of the clip 4 is deployed, the inlet 741 of the lumen 74 in the second holding member 7 opens (opens), and blood in the blood vessel flows in from the inlet 741, and along the lumen 74, the proximal end To the side and out of the outlet 742 (backflushing occurs). By the blood back flush (flash back) from the outflow port 742, the distal end portion of the closure 3 and the clip 4 (seal portion 41) are inserted into the blood vessel, and the seal portion 41 of the clip 4 is expanded. Can be confirmed.

On the other hand, when the seal portion 41 of the clip 4 does not expand, the inflow port 741 is blocked by the seal portion 41, so that the inflow of blood from the inflow port 741 to the lumen 74 is prevented, and blood backflushing occurs. Absent. Thereby, it can confirm that the seal | sticker part 41 of the clip 4 is not expand | deployed.
Thereby, a hemostatic operation can be performed easily and reliably.

  Next, as shown in FIG. 4, the main body 2 is slowly moved in the direction of pulling out from the wound hole, the seal portion 41 of the clip 4 is brought into contact with the inner surface of the blood vessel wall, and the seal portion 41 is used from the inside of the blood vessel wall. Cover the wound and the periphery of the wound. Thereby, the fixing | fixed part 42 of the clip 4 moves to the outer side of the blood vessel.

  In addition, when the wound portion and the peripheral portion of the wound hole are covered from the inside of the blood vessel wall with the seal portion 41 of the clip 4, it is confirmed that the blood backflush from the outflow port 742 disappears. From the disappearance of the backflush and the hand feeling, it can be confirmed that the seal portion 41 of the clip 4 is in contact with the inner surface of the blood vessel wall, whereby the positioning of the clip 4 is completed.

  Next, as shown in FIG. 5, while pulling the first holding member 6, the second holding member 7 and the sheath 5 are rotated in a predetermined direction with respect to the first holding member 6 and moved to the proximal end side. Let Thereby, both ends of the fixing portion 42 of the clip 4 are released from the distal end portion of the second holding member 7 and are inserted into the distal end portion of the second holding member 7 by their own elastic force (restoring force). Restore the original shape (before being held). That is, the fixing portion 42 of the clip 4 is expanded (opened) so as to fix (hold) the sealing portion 41 to the blood vessel wall by sandwiching the blood vessel wall with the seal portion 41 from the outside of the blood vessel wall.

  Thereby, the fixing part 42 covers the wound hole and the peripheral part of the wound hole from the outside of the blood vessel wall, and the seal part 41 covers the wound hole and the peripheral part of the wound hole from the inside of the blood vessel wall. 42, the blood vessel wall is sandwiched and the wound is closed.

Next, as shown in FIG. 6, the main body 2 is moved in the direction of pulling out from the wound hole and removed. At this time, the distal end portion 622 of the holding portion 62 of the first holding member 6 that is fitted in the lower portion 441 of the recess 44 of the clip 4 is detached from the clip 4. That is, the clip 4 is released from the distal end portion 622 of the holding portion 62 of the first holding member 6 and detached from the distal end portion 622 (the distal end portion of the main body portion 2).
Finally, the hemostasis is confirmed and the hemostasis work is completed.

  As described above, according to the in-vivo tissue closing device 1, the flashback lumen 74 that can detect that the seal portion 41 of the clip 4 has been deployed is provided. In the hemostasis operation for the wound formed in the in vivo tissue membrane, it can be confirmed that the seal portion 41 has been expanded, and thus the hemostasis operation can be easily and reliably performed (what the hemostasis operation is You do n’t have to start over). That is, the wound can be easily and reliably closed (closed), and can be completely hemostatic.

Next, a second embodiment of the in vivo tissue closing device of the present invention will be described.
FIG. 7 is a perspective view showing a second embodiment of the in-vivo tissue closing device of the present invention, and FIGS. 8 to 12 are cross-sectional views for explaining the action (operation) of the living tissue suturing device shown in FIG. FIG.

  In this case, although two clips (closing means) 4 are shown in FIG. 7, the shape on the right side in FIG. 7 is a natural state where no external force is applied (when not attached). The left side of FIG. 7 shows the shape when it is attached.

  For convenience of explanation, in FIGS. 8 to 12, the lower left side in the figure is referred to as “tip”, and the upper right side (hand side) is referred to as “base end”.

  Hereinafter, the in-vivo tissue closing device 1 of the second embodiment will be described focusing on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  As shown in FIGS. 7 and 8, in the in-vivo tissue closing device 1 of the second embodiment, the closure (holding means) 3 is a long holding member (tubular member) 8 which is a first holding member. And a thread (thread-like member) 11 that is a second holding member, and a thread cap 9 that is detachably attached to the proximal end portion of the holding member 8.

  The holding member 8 includes a main body (cylindrical portion) 81 having a substantially cylindrical shape (tubular shape) and a hub 82 provided at a base end portion of the main body 81. The inner diameter and the outer diameter of the distal end portion 83 of the main body 81 are set to be smaller than the inner diameter and the outer diameter of the proximal end portion, respectively. The clip 4 is detachably attached to the distal end portion 83 of the holding member 8.

  The hub 82 has a cylindrical tubular portion 821. Ribs 822 that can be engaged with the grooves 53 formed in the hub 52 of the sheath 5 are formed along the circumferential direction on the inner peripheral surface of the tubular portion 821.

  On the outer peripheral surface of the distal end portion 83 of the holding member 8, an inflow port 85 that penetrates the distal end portion 83 and communicates with the through hole 84 (penetrates inside and outside the through hole 84) is provided.

  The thread cap 9 has a substantially cylindrical shape, and its outer diameter gradually increases from the distal end side toward the proximal end side. The thread cap 9 is fitted (attached) to the proximal end portion of the holding member 8.

  The thread cap 9 is provided with a through-hole 91 having an outflow port 92 on the outer peripheral surface and opening at the tip.

  Further, one end side of the thread 11 is fixed to the tip of the thread cap 9. The other end side of the yarn 11 is disposed between the yarn cap 9 and the base end portion of the holding member 8, and the yarn 11 is attached to the base end portion of the holding member 8. 9 and the proximal end portion of the holding member 8 are sandwiched and held, and the through hole 91 of the thread fixing cap 9 and the through hole 84 of the holding member 8 communicate with each other.

  The blood (body fluid) that has flowed into the through hole 84 from the inlet 85 of the holding member 8 flows to the proximal end side through the through holes 84 and 91 and flows out from the outlet 92. The inflow port 85, the through hole 84, the through hole 91, and the outflow port 92 constitute a lumen for flashback.

  The lumen inflow port 85 is closed (closed) by the seal portion 41 before the later-described clip 4 (the seal portion 41 of the clip 4) is deployed. The lumen opens (opens) the inlet 85 when the clip 4 (the seal portion 41 of the clip 4) is deployed, and guides blood (body fluid) flowing from the inlet 85 to the outlet 92. Is possible.

  The inner diameter of the tubular portion 821 of the hub 82 is slightly larger than the outer diameter of the hub 52 of the sheath 5, and the outer diameter of the main body 81 is slightly smaller than the inner diameter of the sheath 5. Thereby, the main body 81 of the holding member 8 can be inserted into the sheath 5, and the hub 52 of the sheath 5 can be inserted into the cylindrical portion 821 of the hub 82 of the holding member 8. The rib 822 can be engaged with the groove 53 of the hub 52. By engaging the rib 822 with the groove 53, the other of the sheath 5 and the holding member 8 is prevented from being detached and the operation becomes easy.

  Further, as shown in FIG. 9, the distal end portion 83 of the holding member 8 is the distal end of the sheath 5 with the closure 3 attached to the sheath 5 (the rib 822 of the hub 82 is engaged with the groove 53 of the hub 52). It comes to protrude from. Thereby, when the closure 3 is attached to the sheath 5, a seal portion 41 of the later-described clip 4 attached to the distal end portion of the closure 3 can be developed.

  As shown in FIGS. 7 and 8, the clip (closing means) 4 includes a seal portion 41 and an elastically deformable fixing portion (support portion) that fixes (holds) the seal portion 41 to the tissue membrane in the living body. 45.

  The seal portion 41 is a member having a flat surface portion 411 that covers a wound hole and a peripheral portion of the wound hole (a portion including the wound hole of the biological tissue film) from one surface (inner surface) side of the biological tissue film. It has a shape. In the illustrated example, the seal portion 41 has a substantially track shape or a substantially oval shape in plan view.

  The fixing portion 42 has a function of fixing (holding) the seal portion 41 to the in vivo tissue membrane by sandwiching the in vivo tissue membrane with the seal portion 41 from the other surface (outer surface) side of the in vivo tissue membrane. Have. The main portion of the fixing portion 45 has a substantially annular shape (in the illustrated example, a substantially annular shape in a natural state where no external force is applied as shown on the right side in FIG. 7), and on the lower side in FIG. The flat surface portion 411 is swingable (rotatable) with respect to the seal portion 41 (the flat surface portion 411) (a hinge portion is provided). In this case, the fixed portion 45 has a central portion of the seal portion 41 such that the rotation center axis 413 is substantially perpendicular to the longitudinal direction of the seal portion 41 and substantially parallel to the flat portion 411. Is arranged.

  The seal portion 41 of the clip 4 is preferably made of a bioabsorbable material. As a result, the seal portion 41 is absorbed by the living body after a predetermined period and finally does not remain in the living body, that is, in the blood vessel (inside the living body lumen), thereby eliminating the influence on the human body. Examples of the bioabsorbable material used are the same as those in the first embodiment described above.

  Moreover, it is preferable that the fixing | fixed part 45 is comprised with the superelastic body which has shape memory property. Examples of the constituent material (raw material) of the fixing portion 45 include a superelastic alloy (superelastic material) such as a nickel-titanium alloy.

  The clip 4 is detachably attached to the distal end portion 83 of the second holding member 8. In this case, the fixing portion 45 of the clip 4 is fitted (attached) to the distal end portion 83 in an elastically deformed state and is detached from the distal end portion 83, so that the original elastic force (restoring force) before the deformation is restored. Restore shape.

  Further, the other end side of the thread 11 whose one end is fixed to the thread cap 9 is inserted through the fixing portion 45 of the clip 4 and pulled out from the base end portion of the holding member 8, and the thread 11 is necessary and sufficient. By attaching the thread clamp cap 9 to the proximal end portion of the holding member 8 in a state where the tension member is stretched, the thread retaining cap 9 and the proximal end portion of the retaining member 8 are sandwiched (held) and held by the retaining member 8. Is held at the proximal end of the. That is, the fixed portion 45 is held on the distal end side (one end side) of the thread 11, and the proximal end side (the other end side) is held on the proximal end portion of the holding member 8 in this state. Thereby, the detachment of the fixing portion 45 of the clip 4 from the tip portion 83 of the holding member 8 is prevented (prevented).

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

  First, as shown in FIG. 8, the closure 3 is assembled, and the clip 4 is attached to the tip of the closure 3.

  In this case, first, the thread 11 is inserted into the through hole 84 from the proximal end portion of the holding member 8, pulled out from the distal end portion 83, inserted through the fixing portion 45 of the clip 4, and from the proximal end portion of the holding member 8. Pull it out.

  Further, the fixing portion 45 of the clip 4 is crushed in the direction of the rotation center axis 413 and elastically deformed, and the fixing portion 45 is inserted into the distal end portion 83 of the holding member 8 and held.

  Then, the thread cap 9 is attached to the proximal end portion of the holding member 8 in a state where the thread 11 is tensioned as necessary and sufficiently. As a result, the fixed portion 45 is held on the distal end side of the yarn 11, and the proximal end side is held on the proximal end portion of the holding member 8 in this state.

  Next, as shown in FIG. 8, the clip 4 together with the closure 3 is inserted into the through hole 51 of the sheath 5 from the proximal end side of the sheath 5. At this time, the seal portion 41 of the clip 4 swings (rotates) with respect to the fixed portion 45, and the flat portion 411 of the seal portion 41 contacts (pressure contact) with the region including the inflow port 85 of the holding member 8. Thus, the inlet 85 is closed (closed) by the seal portion 41.

  Then, the closure 3 is further inserted into the through hole 51 of the sheath 5, and the hub 82 and the hub 52 are fitted to each other as shown in FIG. 9, and the rib 822 of the hub 82 is engaged with the groove 53 of the hub 52. Let Thereby, substantially the entire clip 4 including the seal portion 41 and the distal end portion 83 of the holding member 8 protrude from the distal end portion of the sheath 5, and the clip 4 penetrates the wound hole and is inserted into the blood vessel. At this time, the seal portion 41 of the clip 4 is released from the distal end portion of the sheath 5 and is swung in a direction opposite to that when the clip portion 4 is inserted into the through hole 51 of the sheath 5 by the action of the hinge portion. It moves (rotates) and expands into a form in which the seal portion 41 can cover the wound hole and the peripheral portion of the wound hole from the inside of the blood vessel wall with respect to the distal end portion 83 and the fixing portion 45 of the holding member 8 ( open).

  When the seal portion 41 of the clip 4 is deployed, the inlet 85 of the holding member 8 opens (opens), and blood in the blood vessel flows in from the inlet 85 and flows to the proximal side along the through holes 84 and 91. , And flows out from the outlet 92 (back flush occurs). By the blood back flush (flash back) from the outflow port 92, the distal end portion of the closure 3 and the clip 4 (seal portion 41) are inserted into the blood vessel, and the seal portion 41 of the clip 4 is deployed. Can be confirmed.

On the other hand, when the seal part 41 of the clip 4 does not expand, the inflow port 85 is blocked by the seal part 41, so that the inflow of blood from the inflow port 85 to the through hole 84 is prevented, and the blood backflushing is prevented. Does not occur. Thereby, it can confirm that the seal | sticker part 41 of the clip 4 is not expand | deployed.
Thereby, a hemostatic operation can be performed easily and reliably.

  Next, as shown in FIG. 10, the main body portion 2 is slowly moved in the direction of pulling out from the wound hole, the seal portion 41 of the clip 4 is brought into contact with the inner surface of the blood vessel wall, and the seal portion 41 is used from the inside of the blood vessel wall. Cover the wound and the periphery of the wound. Thereby, the fixing | fixed part 45 of the clip 4 moves to the outer side of the blood vessel.

  In addition, when the wound portion and the peripheral portion of the wound hole are covered from the inside of the blood vessel wall with the seal portion 41 of the clip 4, it is confirmed that the blood backflush from the outflow port 92 disappears. From the disappearance of the backflush and the hand feeling, it can be confirmed that the seal portion 41 of the clip 4 is in contact with the inner surface of the blood vessel wall, whereby the positioning of the clip 4 is completed.

  Next, as shown in FIG. 11, while pulling the main body 2, the thread cap 9 is removed from the proximal end of the holding member 8, and the thread 11 is removed. As a result, the fixing portion 45 of the clip 4 is released from the thread 11, and the fixing portion 45 can be detached from the distal end portion 83 of the holding member 8.

  Next, as shown in FIG. 12, the main body 2 is moved in the direction of pulling out from the flaw hole and removed. At this time, the fixing portion 45 of the clip 4 is released from the distal end portion 83 of the holding member 8 and detached from the distal end portion 83 (the distal end portion of the main body portion 2).

  Thereby, the fixing | fixed part 45 of the clip 4 is restored | restored to the original shape before mounting | wearing with an own elastic force (restoring force). That is, the fixing portion 45 of the clip 4 is expanded (expanded) so as to fix (hold) the seal portion 41 to the blood vessel wall by sandwiching the blood vessel wall with the seal portion 41 from the outside of the blood vessel wall.

Thus, the seal portion 41 covers the wound hole and the peripheral portion of the wound hole from the inside of the blood vessel wall, and the fixing portion 45 seals the blood vessel wall with the seal portion 41 from the outside of the blood vessel wall. The portion 41 is fixed (held), and the wound is closed.
Finally, the hemostasis is confirmed and the hemostasis work is completed.

  According to the in-vivo tissue closing device 1, the same effect as the in-vivo tissue closing device 1 of the first embodiment described above can be obtained.

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

  Further, the present invention may be a combination of any two or more configurations (features) of the above embodiments.

It is sectional drawing which shows 1st Embodiment of the in-vivo tissue closure apparatus of this invention. It is a perspective view which shows the closure means of the in-vivo tissue closure apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is a perspective view which shows 2nd Embodiment of the in-vivo tissue closure apparatus of this invention. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG. It is sectional drawing for demonstrating the effect | action (operation | movement) of the biological tissue suturing apparatus shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Biological tissue closure apparatus 2 Main body part 3 Closure 4 Clip 41 Seal part 411 Plane part 413 Rotation center axis 42, 45 Fixing part 43 Connection part 44 Recession 441 Lower part 442 Upper part 5 Sheath 51 Through-hole 52 Hub 53 groove 6 first holding member 61 main body 611 rib 62 holding portion 621 small diameter portion 622 tip portion 63 flange 7 second holding member 71 main body 72 hub 721 cylindrical portion 722 rib 73 screw groove 74 lumen 741 inflow port 742 outflow port DESCRIPTION OF SYMBOLS 8 Holding member 81 Main body 82 Hub 821 Cylindrical part 822 Rib 83 Tip part 84 Through-hole 85 Inlet 9 Thread cap 9 91 Through-hole 92 Outlet 11 Yarn

Claims (23)

An in-vivo tissue closing device for closing a wound penetrating an in-vivo tissue membrane,
An elongate main body that allows the tip to penetrate the wound,
Removably attached to the distal end portion of the main body portion, and capable of penetrating the wound hole together with the distal end portion of the main body portion, comprising a closing means for closing the wound hole,
The closing means includes a seal part that covers the wound hole and a peripheral part of the wound hole from one surface side of the in-vivo tissue film, and a fixing part that fixes the seal part to the in-vivo tissue film. The seal part is developed in a form that can cover the wound hole and the peripheral part of the wound hole in a state where the seal part is attached to the tip of the main body part and penetrates the wound hole. Yes,
The main body has an inflow opening that opens when the closing means is deployed, and includes a lumen that guides body fluid flowing from the inflow opening, and the closing means is attached to the distal end of the main body. And an in-vivo tissue closing device comprising detecting means for detecting that the wound has been deployed through the wound. An in-vivo tissue closing device for closing a wound penetrating an in-vivo tissue membrane,
An elongate main body that allows the tip to penetrate the wound,
Removably attached to the distal end portion of the main body portion, and capable of penetrating the wound hole together with the distal end portion of the main body portion, comprising a closing means for closing the wound hole,
The closing means includes the seal portion covering the wound hole and a peripheral portion of the wound hole from one surface side of the in vivo tissue membrane, and the seal portion from the other surface side of the in vivo tissue membrane. A fixing part for fixing the seal part to the in vivo tissue membrane by sandwiching the body tissue membrane, and attached to the distal end portion of the main body part and penetrating the wound, The seal part is developed in a form capable of covering the wound hole and the peripheral part of the wound hole,
The main body has an inflow opening that opens when the closing means is deployed, and includes a lumen that guides body fluid flowing from the inflow opening, and the closing means is attached to the distal end of the main body. And an in-vivo tissue closing device comprising detecting means for detecting that the wound has been deployed through the wound. The in-vivo tissue closure device according to claim 1 or 2, wherein the in-vivo tissue membrane is a blood vessel wall, and the one surface is an inner surface of the blood vessel wall . The in-vivo tissue closing device according to any one of claims 1 to 3 , wherein the inflow port is closed by the seal portion before the closing means is deployed.   The in-vivo tissue closing device according to any one of claims 1 to 4, wherein the main body portion includes a holding unit that detachably holds the closing unit.   The in-vivo tissue closing device according to claim 5, wherein the holding means holds at least the fixing portion of the closing means.   The fixing part of the closing means moves the main body part in the direction of pulling out from the wound hole with respect to the closing means in a state in which the seal part is deployed and is in contact with one surface of the in vivo tissue membrane. The living body according to claim 6, wherein the living body according to claim 6 is configured so as to be released from the holding means and detached from the distal end portion of the main body portion and to be deployed so as to fix the seal portion to the tissue tissue in the living body. Body tissue closure device.   The said closing means has a recessed part with which the said holding means fits, and when the said holding means fits into this recessed part, it attaches to the front-end | tip part of the said main-body part so that attachment or detachment is possible. In vivo tissue closure device. The holding means has a long first holding member and a long second holding member,
The closing means has a recess into which the first holding member is fitted, and the first holding member is fitted into the recess, and the fixing portion is held by the second holding member. The in-vivo tissue closing device according to claim 5 or 6, wherein the in-vivo tissue closing device is configured to be detachably attached to a distal end portion of the main body portion.   The fixing portion of the closing means is a direction in which the second holding member is pulled out from the wound hole with respect to the closing means in a state where the seal portion is expanded and is in contact with one surface of the tissue tissue in the living body. The in-vivo tissue closing device according to claim 9, wherein the in-vivo tissue closing device is configured to be released from the second holding member by being moved to be deployed so as to fix the seal portion to the in-vivo tissue membrane. .   The closing means moves the first holding member with respect to the closing means in a direction of pulling out from the wound hole in a state in which the seal portion is deployed and is in contact with one surface of the in vivo tissue membrane. The in-vivo tissue closing device according to claim 10, wherein the in-vivo tissue closing device is released from the first holding member and detached from the distal end portion of the main body.   The in vivo tissue closure according to any one of claims 9 to 11, wherein the second holding member has a cylindrical portion having a substantially cylindrical shape, and the first holding member is inserted into the cylindrical portion. apparatus.   The structure according to any one of claims 9 to 12, wherein the second holding member is configured to move relative to the first holding member along a longitudinal direction of the second holding member. In vivo tissue closure device.   The in-vivo tissue closure device according to any one of claims 1 to 13, wherein the seal portion and the fixing portion are each elastically deformable.   The in-vivo tissue closing device according to claim 14, wherein the seal part and the fixing part are each in a plate-like shape and are opposed to each other in a natural state.   The in-vivo tissue closing device according to any one of claims 1 to 15, wherein the seal portion and the fixing portion are integrally formed.   The holding means has a thread-like member, and is configured such that the fixing portion of the closing means is held on one end side of the thread-like member, and the other end side of the thread-like member is held on the proximal end side of the main body portion. The in-vivo tissue closure device according to claim 5 or 6.   The fixing portion of the closing means is released from the thread-like member, and the seal portion is unfolded and abuts against one surface of the tissue tissue in the living body, and the main body portion is in contact with the closing means. By moving in a direction to remove from the wound hole, it is released from the holding means and detached from the distal end portion of the main body portion, and is configured to be deployed so as to fix the seal portion to the tissue tissue in vivo. The in-vivo tissue closure device according to claim 17.   The in-vivo tissue closing device according to any one of claims 1 to 7, 17, and 18, wherein the fixing portion is elastically deformable.   The in-vivo tissue closing device according to any one of claims 1 to 7, and 17 to 19, wherein the fixing portion has a substantially annular shape.   The in-vivo tissue closure device according to any one of claims 1 to 7, and 17 to 20, wherein the fixing portion is provided to be swingable with respect to the seal portion.   The in-vivo tissue closing device according to any one of claims 1 to 7, and 17 to 21, wherein the seal portion has a plate shape.   The in-vivo tissue closing device according to any one of claims 1 to 22, wherein at least a part of the closing means is made of a bioabsorbable material.

Images